Type 2 Diabetes MellitusPhase 1NCT02430870
TAK-648 Multiple-Rising Dose Study in Healthy Japanese Participants and Non-Japanese Participants With Type 2 Diabetes Mellitus
A Phase 1 study testing TAK-648 in people with Type 2 Diabetes Mellitus, run by Takeda at 2 sites in United States.
Trial summary
This is a phase 1, randomized, double-blind, placebo-controlled, 2-center, multiple-dose study in healthy participants and participants with type 2 diabetes mellitus (T2DM). This study will evaluate the safety, tolerability and pharmacokinetics (PK) of TAK-648 when administered as multiple oral doses of TAK-648… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- TAK-648
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Nov 2015
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1:
- Is an adult male or female and has a historical diagnosis of type 2 diabetes mellitus (T2DM) disease.
- Is aged 18 to 65 years, inclusive, at the time of informed consent and first study medication dose.
- Weighs at least 55 kg and has a body mass index (BMI) ≥23.0 kg/m^2 and ≤35.0 kg/m^2 at Screening.
- Has a systolic blood pressure >90 and ≤150 mm Hg and a diastolic blood pressure of >60 and ≤90 mm Hg at Screening and at Check-in (Day -2). If out of range, may be repeated once for eligibility determination within a maximum of5 minutes.
- Has a calculated creatinine clearance >60 mL/min at Screening and Check-in (Day -2).
Show all 16Show fewer
- Has been treated for inadequate glycemic control with a stable dose of metformin for the least 8 weeks prior to Screening.
- Has a glycosylated hemoglobin (HbA1c) level between 6.5% and 10.0%, inclusive at Check-in (Day -2).
- Has a fasting C-peptide concentration ≥0.8 ng/mL at Screening.
- Has no medical history of type 1 diabetes mellitus (T1DM), hypoglycemia unawareness, diabetic ketoacidosis or hyperosmolar coma.
- Part 2:
- Is a healthy adult male or female of Japanese descent (born to Japanese parents and grandparents) and have lived outside of Japan for less than 5 years, inclusive.
- Is aged 20 to 55 years, inclusive, at the time of informed consent and first study medication dose.
- Weighs at least 45 kg and has a BMI from 17.0 to 25.0 kg/m^2, inclusive at Screening.
- Has a systolic blood pressure >90 and ≤150 mm Hg and a diastolic blood pressure of >60 and ≤90 mm Hg at Screening and at Check-in (Day -2). If out of range, may be repeated once for eligibility determination within a maximum of 5 minutes.
- Has a calculated creatinine clearance >60 mL/min at Screening and Check-in (Day -2).
Who cannot join
- Part 1:
- Has Screening or Check-in (Day -2) laboratory values of serum creatinine ≥1.5 mg/dL for males or ≥1.4 mg/dL [females] or abnormal creatinine clearance.
- Has a history of T1DM, hypoglycemia unawareness, diabetic ketoacidosis, or hyperosmolar coma.
- Has a history of any clinically significant retinopathy, which is defined as more than moderate nonproliferative diabetic retinopathy or any stage of proliferative diabetic retinopathy or any history of laser-treated retinopathy.
- Has received any antihyperglycemic medication with the exception of metformin within the previous 12 weeks of Check-in (Day -2) or the subject has changed the dose of metformin within the previous 8 weeks of Screening.
- Is expecting to receive, receiving or has received systemic glucocorticoid therapy for a duration longer than 5 days within the previous 12 weeks of Check-in (Day -2).
Show all 26Show fewer
- Parts 1 and 2:
- Has received any investigational compound within 30 days prior to the first dose of study medication.
- Has received TAK-648 in a previous clinical study or as a therapeutic agent.
- Has any significant medical histories or currently uncontrolled clinical conditions, which may not be safe for participants to participate in the study, may impact the ability of the participant to participate in the study, or may potentially confound the study results. The concerned significant medical histories and uncontrolled clinical conditions include (may not be limited to) cardiovascular (such as ischemic heart disease, heart failure, cardiomyopathy, clinically significant arrhythmia, uncontrolled or unstable blood pressure), central nervous system, hepatic or hematopoietic disease(s), renal dysfunction, metabolic or endocrine dysfunction, pulmonary diseases including serious allergy and asthma hypoxemia, seizures, or allergic skin rash.
- Has a history of significant GI disorders manifested with persistent, chronic or intermittent nausea, vomiting or diarrhea, or has a current or recent (within 6 months) GI disease that would influence the absorption of drugs (eg, a history or malabsorption, severe esophageal reflux, peptic ulcer disease or erosive esophagitis with frequent [more than once per week] occurrence of heartburn).
- Has diagnosis of major depression, bipolar disorder or anxiety disorders, or has a risk of anxiety, depression, or insomnia according to the investigator's clinical judgment per HAM-D17 at Screening or has received any medication to treat any psychological disorders within 1 year.
- Has a risk of suicide according to the investigator's clinical judgment per C-SSRS at Screening or has made a suicide attempt in the past 6 months prior to Screening.
- Has a known hypersensitivity to any component of the formulation ofTAK-648, or to a PDE4 inhibitor (eg, roflumilast) or Listerine strips.
- Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -2).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
- Has taken any excluded medication, supplements, or food products.
- If female, is pregnant or lactating or intending to become pregnant before, during, or within 12 weeks after participating in this study; or intending to donate ova during such time period.
- If male, intends to donate sperm during the course of this study or for 12 weeks thereafter.
- Has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years prior to Day 1.
- Has a positive test result for HBsAg, anti-HCV, at Screening or a known history of human immunodeficiency virus infection.
- Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 6 weeks prior to Check-in (Day -2). Cotinine test is positive at Screening or Check-in (Day -2).
- Has poor peripheral venous access.
- Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1.
- Has a Screening or Check-in (Day -2) abnormal (clinically significant) ECG, including but not limited to those with evidence of prolonged QT/QTc interval at Baseline (eg, QTc interval >450 milliseconds) or those at risk for QT prolongation (eg with a family history of long QT syndrome). Entry of any subject with an abnormal (not clinically significant) ECG must be approved, and documented by signature by the principal investigator or medically qualified subinvestigator.
- Has abnormal Screening or Check-in (Day -2) laboratory values that suggest a clinically significant underlying disease or participant with the following laboratory abnormalities: ALT and/or AST >2.5×ULN.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Anaheim, California
Study site
Chula Vista, California
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Multiple Oral TAK-648 Doses in Healthy Japanese Subjects and Subjects With Type 2 Diabetes Mellitus
This is a phase 1, randomized, double-blind, placebo-controlled, 2-center, multiple-dose study in healthy participants and participants with type 2 diabetes mellitus (T2DM). This study will evaluate the safety, tolerability and pharmacokinetics (PK) of TAK-648 when administered as multiple oral doses of TAK-648 solution at escalating dose levels in healthy participants of Japanese decent and participants with T2DM.
Read the detailed description
The drug being evaluated in this study is TAK-648 for the treatment of T2DM.
This study will consist of 2 parts: (1) multiple ascending doses in participants with T2DM treated with a stable dose of metformin, (2) multiple ascending doses in healthy participants of Japanese descent.
Part 1 of this study will consist of 2 multiple dose treatment cohorts (Cohorts 1-2 designated as P1C1 and P1C2) dosed sequentially in escalating order. The projected doses of TAK-648 for Part 1 are 0.15 and 0.35 mg of TAK-648, but may be adjusted higher or lower, and additional cohorts may be added, based on available safety and pharmacokinetic (PK) data. All cohorts in Part 1 will consist of 8 (2 placebo) T2DM participants.
Part 2 of this study will consist of 3 multiple dose treatment cohorts (Cohorts 1-3 designated as P2C1, P2C2 and P2C3) in healthy participants of Japanese descent dosed sequentially in escalating order. The projected doses of TAK-648 chosen for Part 2 are 0.05, 0.15 and 0.35 mg of TAK-648, but may be adjusted higher or lower based on available safety and PK data. All cohorts in Part 2 will consist of 8 (2 placebo) healthy participants of Japanese descent.
Additional cohorts may be recruited and studied as necessary to better evaluate safety, tolerability, PK, and/or PD parameters.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- TAK-648, Placebo
- Keywords
- Drug therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-648Drug
TAK-648 solution
PlaceboDrug
TAK-648 placebo-matching solution
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1: TAK-648 0.35 mg | Experimental | Participants with T2DM on a stable dose of metformin in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). Receives: Drug: TAK-648 |
| Part 1 Cohort 2: TAK-648 0.80 mg | Experimental | Participants with T2DM on a stable dose of metformin in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). Receives: Drug: TAK-648 |
| Part 1: Placebo Cohort 1-2 | Placebo comparator | Participants with T2DM on a stable dose of metformin in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). Receives: Drug: Placebo |
| Part 2 Cohort 1: TAK-648 0.05 mg | Experimental | Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). Receives: Drug: TAK-648 |
| Part 2 Cohort 2: TAK-648 0.15 mg | Experimental | Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). Receives: Drug: TAK-648 |
| Part 2 Cohort 3: TAK-648 0.35 mg | Experimental | Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). Receives: Drug: TAK-648 |
| Part 2 Cohort 4: TAK-648 0.80 mg | Experimental | Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). Receives: Drug: TAK-648 |
| Part 2: Placebo Cohort 1-4 | Placebo comparator | Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 1
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Up to Day 34
Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 2
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: Up to Day 26
Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 1
Measured: Up to Day 20
Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 2
Measured: Up to Day 13
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 1
Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm).
Measured: Up to Day 20
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 2
Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm),
Measured: Up to Day 13
Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 1
Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Measured: Up to Day 20
Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 2
Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Measured: Up to Day 13
Secondary outcomes (10)
Cmax: Maximum Plasma Concentration for TAK-648 for Part 1
Measured: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)
Cmax: Maximum Plasma Concentration for TAK-648 for Part 2
Measured: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)
Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 1
Measured: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)
Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 2
Measured: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 1
Measured: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 2
Measured: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 1
Measured: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 2
Measured: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 1
Measured: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 2
Measured: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionNov 2015
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430870
- Sponsor's protocol ID
- TAK-648-1002
- Other IDs
- U1111-1165-3437
- Status last verified
- Jul 2016
- First submitted
- 24 Apr 2015
- Last updated
- 31 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Multiple Oral TAK-648 Doses in Healthy Japanese Subjects and Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02430870
- Acronym / sponsor ID
- TAK-648-1002
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Posted 31 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1, randomized, double-blind, placebo-controlled, 2-center, multiple-dose study in healthy participants and participants with type 2 diabetes mellitus (T2DM). This study will evaluate the safety, tolerability and pharmacokinetics (PK) of TAK-648 when administered as multiple oral doses of TAK-648 solution at escalating dose levels in healthy participants of Japanese decent and participants with T2DM.
Detailed description
The drug being evaluated in this study is TAK-648 for the treatment of T2DM.
This study will consist of 2 parts: (1) multiple ascending doses in participants with T2DM treated with a stable dose of metformin, (2) multiple ascending doses in healthy participants of Japanese descent.
Part 1 of this study will consist of 2 multiple dose treatment cohorts (Cohorts 1-2 designated as P1C1 and P1C2) dosed sequentially in escalating order. The projected doses of TAK-648 for Part 1 are 0.15 and 0.35 mg of TAK-648, but may be adjusted higher or lower, and additional cohorts may be added, based on available safety and pharmacokinetic (PK) data. All cohorts in Part 1 will consist of 8 (2 placebo) T2DM participants.
Part 2 of this study will consist of 3 multiple dose treatment cohorts (Cohorts 1-3 designated as P2C1, P2C2 and P2C3) in healthy participants of Japanese descent dosed sequentially in escalating order. The projected doses of TAK-648 chosen for Part 2 are 0.05, 0.15 and 0.35 mg of TAK-648, but may be adjusted higher or lower based on available safety and PK data. All cohorts in Part 2 will consist of 8 (2 placebo) healthy participants of Japanese descent.
Additional cohorts may be recruited and studied as necessary to better evaluate safety, tolerability, PK, and/or PD parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1: TAK-648 0.35 mg | Experimental | Drug: TAK-648Participants with T2DM on a stable dose of metformin in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| Part 1 Cohort 2: TAK-648 0.80 mg | Experimental | Drug: TAK-648Participants with T2DM on a stable dose of metformin in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| Part 1: Placebo Cohort 1-2 | Placebo comparator | Drug: PlaceboParticipants with T2DM on a stable dose of metformin in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days). |
| Part 2 Cohort 1: TAK-648 0.05 mg | Experimental | Drug: TAK-648Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| Part 2 Cohort 2: TAK-648 0.15 mg | Experimental | Drug: TAK-648Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| Part 2 Cohort 3: TAK-648 0.35 mg | Experimental | Drug: TAK-648Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| Part 2 Cohort 4: TAK-648 0.80 mg | Experimental | Drug: TAK-648Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
| Part 2: Placebo Cohort 1-4 | Placebo comparator | Drug: PlaceboHealthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Is an adult male or female and has a historical diagnosis of type 2 diabetes mellitus (T2DM) disease.
- Is aged 18 to 65 years, inclusive, at the time of informed consent and first study medication dose.
- Weighs at least 55 kg and has a body mass index (BMI) ≥23.0 kg/m^2 and ≤35.0 kg/m^2 at Screening.
- Has a systolic blood pressure >90 and ≤150 mm Hg and a diastolic blood pressure of >60 and ≤90 mm Hg at Screening and at Check-in (Day -2). If out of range, may be repeated once for eligibility determination within a maximum of5 minutes.
- Has a calculated creatinine clearance >60 mL/min at Screening and Check-in (Day -2).
Key exclusion criteria (26 listed)
- Has Screening or Check-in (Day -2) laboratory values of serum creatinine ≥1.5 mg/dL for males or ≥1.4 mg/dL [females] or abnormal creatinine clearance.
- Has a history of T1DM, hypoglycemia unawareness, diabetic ketoacidosis, or hyperosmolar coma.
- Has a history of any clinically significant retinopathy, which is defined as more than moderate nonproliferative diabetic retinopathy or any stage of proliferative diabetic retinopathy or any history of laser-treated retinopathy.
- Has received any antihyperglycemic medication with the exception of metformin within the previous 12 weeks of Check-in (Day -2) or the subject has changed the dose of metformin within the previous 8 weeks of Screening.
- Is expecting to receive, receiving or has received systemic glucocorticoid therapy for a duration longer than 5 days within the previous 12 weeks of Check-in (Day -2).
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 |
|---|---|---|
| TAK-648TAK-648 solution | Drug | Part 1 Cohort 1: TAK-648 0.35 mg, Part 1 Cohort 2: TAK-648 0.80 mg, Part 2 Cohort 1: TAK-648 0.05 mg, Part 2 Cohort 2: TAK-648 0.15 mg, Part 2 Cohort 3: TAK-648 0.35 mg, Part 2 Cohort 4: TAK-648 0.80 mg |
| PlaceboTAK-648 placebo-matching solution | Drug | Part 1: Placebo Cohort 1-2, Part 2: Placebo Cohort 1-4 |
Primary outcome
Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 1
Time frame: Up to Day 34
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 2
Time frame: Up to Day 26
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 1
Time frame: Up to Day 20
Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 2
Time frame: Up to Day 13
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 1
Time frame: Up to Day 20
Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm).
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 2
Time frame: Up to Day 13
Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm),
Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 1
Time frame: Up to Day 20
Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 2
Time frame: Up to Day 13
Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
10 secondary outcomes
Cmax: Maximum Plasma Concentration for TAK-648 for Part 1
Time frame: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)
Cmax: Maximum Plasma Concentration for TAK-648 for Part 2
Time frame: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)
Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 1
Time frame: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)
Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 2
Time frame: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 1
Time frame: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 2
Time frame: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 1
Time frame: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 2
Time frame: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 1
Time frame: Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)
AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 2
Time frame: Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Medical Director study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-648 in people with Type 2 Diabetes Mellitus, run by Takeda at 2 sites in United States.
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 16 inclusion and 26 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 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 31 Aug 2016). 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?
Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 1 (time frame: Up to Day 34). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2016.