Type 2 Diabetes MellitusPhase 2/3NCT01263509
Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
A Phase 2/3 study testing Alogliptin and voglibose in people with Type 2 Diabetes Mellitus, run by Takeda.
Trial summary
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on study. Read more about this study
- Who is it for?
- Ages 33 to 85 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Alogliptin and voglibose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Oct 2008
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).
Who cannot join
- Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
- Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
About this study
Official title: A Long-term, Open-label Extension Study to Investigate the Long-term Safety of SYR-322 When Used in Combination With α-glucosidase Inhibitor in Subjects With Type 2 Diabetes in Japan
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on study.
Read the detailed description
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.
"To evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who completed a phase 2/3 α-glucosidase inhibitor add on study 322/CCT-003 (NCT01263483).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Alogliptin and voglibose
- Keywords
- Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alogliptin and vogliboseDrug
Also called SYR-322, Voglibose, BASEN®
Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Alogliptin and vogliboseDrug
Also called SYR-322, Voglibose, BASEN®
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID | Experimental | Not described Receives: Drug: Alogliptin and voglibose |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Experimental | Not described Receives: Drug: Alogliptin and voglibose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events.
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.
Measured: 52 Weeks.
Secondary outcomes (59)
Change From Baseline in Glycosylated Hemoglobin (Week 8).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Glycosylated Hemoglobin (Week 12).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Glycosylated Hemoglobin (Week 16).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 16.
Change From Baseline in Glycosylated Hemoglobin (Week 20).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 20.
Change From Baseline in Glycosylated Hemoglobin (Week 24).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Glycosylated Hemoglobin (Week 28).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 28.
Change From Baseline in Glycosylated Hemoglobin (Week 32).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 32.
Change From Baseline in Glycosylated Hemoglobin (Week 36).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 36.
Change From Baseline in Glycosylated Hemoglobin (Week 40).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 40.
Change From Baseline in Glycosylated Hemoglobin (Week 44).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 44.
Change From Baseline in Glycosylated Hemoglobin (Week 48).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 48.
Change From Baseline in Glycosylated Hemoglobin (Week 52).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 52.
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Final Visit (up to Week 52).
Change From Baseline in Fasting Plasma Glucose (Week 8).
The change between the value of fasting plasma glucose collected at week 8 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 12).
The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Fasting Plasma Glucose (Week 16).
The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 16.
Change From Baseline in Fasting Plasma Glucose (Week 20).
The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 20.
Change From Baseline in Fasting Plasma Glucose (Week 24).
The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Fasting Plasma Glucose (Week 28).
The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 28.
Change From Baseline in Fasting Plasma Glucose (Week 32).
The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 32.
Change From Baseline in Fasting Plasma Glucose (Week 36).
The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 36.
Change From Baseline in Fasting Plasma Glucose (Week 40).
The change between the value of fasting plasma glucose collected at week 40 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 40.
Change From Baseline in Fasting Plasma Glucose (Week 44).
The change between the value of fasting plasma glucose collected at week 44 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 44.
Change From Baseline in Fasting Plasma Glucose (Week 48).
The change between the value of fasting plasma glucose collected at week 48 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 48.
Change From Baseline in Fasting Plasma Glucose (Week 52).
The change between the value of fasting plasma glucose collected at week 52 and fasting plasma glucose collected at baseline.
Measured: Baseline and Week 52.
Change From Baseline in Fasting Plasma Glucose (Final Visit).
The change between the value of fasting plasma glucose collected at week 52 or final visit and fasting plasma glucose collected at baseline.
Measured: Baseline and Final Visit (up to Week 52).
Change From Baseline in Fasting C-peptide (Week 8).
The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Fasting C-peptide (Week 12).
The change between the value of fasting C-peptide collected at week 12 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Fasting C-peptide (Week 16).
The change between the value of fasting C-peptide collected at week 16 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 16.
Change From Baseline in Fasting C-peptide (Week 20).
The change between the value of fasting C-peptide collected at week 20 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 20.
Change From Baseline in Fasting C-peptide (Week 24).
The change between the value of fasting C-peptide collected at week 24 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Fasting C-peptide (Week 28).
The change between the value of fasting C-peptide collected at week 28 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 28.
Change From Baseline in Fasting C-peptide (Week 32).
The change between the value of fasting C-peptide collected at week 32 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 32.
Change From Baseline in Fasting C-peptide (Week 36).
The change between the value of fasting C-peptide collected at week 36 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 36.
Change From Baseline in Fasting C-peptide (Week 40).
The change between the value of fasting C-peptide collected at week 40 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 40.
Change From Baseline in Fasting C-peptide (Week 44).
The change between the value of fasting C-peptide collected at week 44 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 44.
Change From Baseline in Fasting C-peptide (Week 48).
The change between the value of fasting C-peptide collected at week 48 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 48.
Change From Baseline in Fasting C-peptide (Week 52).
The change between the value of fasting C-peptide collected at week 52 and fasting C-peptide collected at baseline.
Measured: Baseline and Week 52.
Change From Baseline in Fasting C-peptide (Final Visit).
The change between the value of fasting C-peptide collected at week 52 or final visit and fasting C-peptide collected at baseline.
Measured: Baseline and Final Visit (up to Week 52).
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 24).
The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 24.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 52).
The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 52.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Final Visit).
The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Final Visit (up to Week 52).
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
The change between the value of blood glucose collected at week 12 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
The change between the value of blood glucose collected at week 24 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 24.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
The change between the value of blood glucose collected at week 52 and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 52.
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
The change between the value of blood glucose collected at week 52 or final visit and blood glucose collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Final Visit (up to Week 52).
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
The change between the value of insulin collected at week 12 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 12.
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
The change between the value of insulin collected at week 24 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 24.
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
The change between the value of insulin collected at week 52 and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 52.
Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
The change between the value of insulin collected at week 52 or final visit and insulin collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Final Visit (up to Week 52).
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 12).
The change between the value of C-peptide collected at week 12 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 12.
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 24).
The change between the value of C-peptide collected at week 24 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 24.
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Week 52).
The change between the value of C-peptide collected at week 52 and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 52.
Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2)) (Final Visit).
The change between the value of C-peptide collected at week 52 or final visit and C-peptide collected at baseline as measured by the meal tolerance test. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Final Visit (up to Week 52).
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 12).
The change between the value of glucagons collected at week 12 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 12.
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 24).
The change between the value of glucagons collected at week 24 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 24.
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Week 52).
The change between the value of glucagons collected at week 52 and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Week 52.
Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)) (Final Visit).
The change between the value of glucagons collected at week 52 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon through blood samples drawn before a meal and 2 hours after the start of the meal.
Measured: Baseline and Final Visit (up to Week 52).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2010 (estimated)
- Study startJun 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor, Department of Medicine, Study director, Kawasaki Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263509
- Sponsor's protocol ID
- SYR-322/OCT-003
- Other IDs
- U1111-1118-3992
- Status last verified
- Feb 2012
- First submitted
- 17 Dec 2010
- Last updated
- 3 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Seino Y, Fujita T, Hiroi S, Hirayama M, Kaku K. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension. Curr Med Res Opin. 2011 Nov;27 Suppl 3:21-9. doi: 10.1185/03007995.2011.614936.
PubMed 22106975
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term, Open-label Extension Study to Investigate the Long-term Safety of SYR-322 When Used in Combination With α-glucosidase Inhibitor in Subjects With Type 2 Diabetes in Japan
- ClinicalTrials.gov ID
- NCT01263509
- Acronym / sponsor ID
- SYR-322/OCT-003
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Dec 2010 (estimated)
- Results
- Posted 29 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on study.
Detailed description
Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.
"To evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who completed a phase 2/3 α-glucosidase inhibitor add on study 322/CCT-003 (NCT01263483).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID | Experimental | Drug: Alogliptin and voglibose |
| Alogliptin 25 mg QD and Voglibose 0.2 mg TID | Experimental | Drug: Alogliptin and voglibose |
Who may qualify
- Ages
- 33 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).
Key exclusion criteria (2 listed)
- Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
- Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alogliptin and vogliboseAlso: SYR-322, Voglibose, BASEN®Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. | Drug | Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID |
| Alogliptin and vogliboseAlso: SYR-322, Voglibose, BASEN®Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks. | Drug | Alogliptin 25 mg QD and Voglibose 0.2 mg TID |
Primary outcome
Number of Participants With Adverse Events.
Time frame: 52 Weeks.
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date >30) will be listed, but not included in the summary tables below.
59 secondary outcomes
Change From Baseline in Glycosylated Hemoglobin (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Glycosylated Hemoglobin (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Glycosylated Hemoglobin (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Glycosylated Hemoglobin (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Glycosylated Hemoglobin (Week 24).
Time frame: Baseline and Week 24.
Change From Baseline in Glycosylated Hemoglobin (Week 28).
Time frame: Baseline and Week 28.
Change From Baseline in Glycosylated Hemoglobin (Week 32).
Time frame: Baseline and Week 32.
Change From Baseline in Glycosylated Hemoglobin (Week 36).
Time frame: Baseline and Week 36.
Change From Baseline in Glycosylated Hemoglobin (Week 40).
Time frame: Baseline and Week 40.
Change From Baseline in Glycosylated Hemoglobin (Week 44).
Time frame: Baseline and Week 44.
Change From Baseline in Glycosylated Hemoglobin (Week 48).
Time frame: Baseline and Week 48.
Change From Baseline in Glycosylated Hemoglobin (Week 52).
Time frame: Baseline and Week 52.
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
Time frame: Baseline and Final Visit (up to Week 52).
Change From Baseline in Fasting Plasma Glucose (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Fasting Plasma Glucose (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Fasting Plasma Glucose (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Fasting Plasma Glucose (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Fasting Plasma Glucose (Week 24).
Time frame: Baseline and Week 24.
Change From Baseline in Fasting Plasma Glucose (Week 28).
Time frame: Baseline and Week 28.
Change From Baseline in Fasting Plasma Glucose (Week 32).
Time frame: Baseline and Week 32.
Change From Baseline in Fasting Plasma Glucose (Week 36).
Time frame: Baseline and Week 36.
Change From Baseline in Fasting Plasma Glucose (Week 40).
Time frame: Baseline and Week 40.
Change From Baseline in Fasting Plasma Glucose (Week 44).
Time frame: Baseline and Week 44.
Change From Baseline in Fasting Plasma Glucose (Week 48).
Time frame: Baseline and Week 48.
Change From Baseline in Fasting Plasma Glucose (Week 52).
Time frame: Baseline and Week 52.
Change From Baseline in Fasting Plasma Glucose (Final Visit).
Time frame: Baseline and Final Visit (up to Week 52).
Change From Baseline in Fasting C-peptide (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Fasting C-peptide (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Fasting C-peptide (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Fasting C-peptide (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Fasting C-peptide (Week 24).
Time frame: Baseline and Week 24.
Change From Baseline in Fasting C-peptide (Week 28).
Time frame: Baseline and Week 28.
Change From Baseline in Fasting C-peptide (Week 32).
Time frame: Baseline and Week 32.
Change From Baseline in Fasting C-peptide (Week 36).
Time frame: Baseline and Week 36.
Change From Baseline in Fasting C-peptide (Week 40).
Time frame: Baseline and Week 40.
Change From Baseline in Fasting C-peptide (Week 44).
Time frame: Baseline and Week 44.
Change From Baseline in Fasting C-peptide (Week 48).
Time frame: Baseline and Week 48.
Change From Baseline in Fasting C-peptide (Week 52).
Time frame: Baseline and Week 52.
Change From Baseline in Fasting C-peptide (Final Visit).
Time frame: Baseline and Final Visit (up to Week 52).
Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value) (Week 12).
Time frame: Baseline and Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22106975Seino Y, Fujita T, Hiroi S, Hirayama M, Kaku K. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension. Curr Med Res Opin. 2011 Nov;27 Suppl 3:21-9. doi: 10.1185/03007995.2011.614936.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor, Department of Medicine study director
Kawasaki Medical School
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alogliptin and voglibose in people with Type 2 Diabetes Mellitus, run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events. (time frame: 52 Weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2012.