Diabetes Mellitus Type 2Phase 3NCT01871415
A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy
A Phase 3 study testing aleglitazar and metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 7 sites in 2 countries.
Trial summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar in combination with metformin in patients with Type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- aleglitazar and metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 7 sitesin 2 countries
- Study dates
- May 2013to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient, >/= 18 years of age
- Type 2 diabetes mellitus treated with stable metformin monotherapy for at least 12 weeks prior to screening; metformin dose should be >/= 1500 mg/day (or individual maximum tolerated dose), but no more than the maximum dose specified in the label
- HbA1c >/= 7% and </= 9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
- Fasting plasma glucose </= 13.3 mmol/L (</= 240 mg/dL) at pre-randomization visit
- Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study
Who cannot join
- Pregnant women, women intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods
- Diagnosis or history of:
- Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
- Any previous treatment with thiazolidinedione or with a dual PPAR agonist
- Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (>= 1 month) statin therapy
Show all 18Show fewer
- Prior intolerance to fibrate
- Treatment with anti-diabetic medication other than metformin in the last 12 weeks prior to screening
- Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening
- Clinically apparent liver disease
- Anemia at or within 4 weeks prior to screening
- Inadequate renal function
- Symptomatic congestive heart failure NYHA Class II-IV at screening
- Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit
- Known macular edema at screening or prior to screening visit
- Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
- Uncontrolled hypertension
- History of active substance abuse (including alcohol) within the past 2 years
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
China4 sites
Study site
Shanghai, 200003
Study site
Shenyang, 110004
Study site
Shiyan, 442000
Study site
Suzhou, 215004
South Korea3 sites
Study site
Gyeonggi-do, 463-712
Study site
Incheon, 405-760
Study site
Seoul, 150-950
About this study
Official title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF ALEGLITAZAR PLUS METFORMIN COMBINATION THERAPY COMPARED WITH PLACEBO PLUS METFORMIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED WITH METFORMIN MONOTHERAPY
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar in combination with metformin in patients with Type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks in combination with their pre-existing metformin regimen and dose.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- aleglitazar, metformin, placebo
- 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.
aleglitazarDrug
150 mcg orally daily
metforminDrug
pre-existing background regimen and dose
placeboDrug
matching aleglitazar placebo orally daily
| Study group | Role | What they receive |
|---|---|---|
| Aleglitazar + metformin | Experimental | Not described Receives: Drug: aleglitazar; Drug: metformin |
| Placebo + metformin | Active comparator | Not described Receives: Drug: metformin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: from baseline to Week 26
Secondary outcomes (7)
Change in lipids
Measured: from baseline to Week 26
Change in fasting plasma glucose (FPG)
Measured: from baseline to Week 26
Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26
Measured: 26 weeks
Change in homeostatic index of insulin sensitivity (by HOMA-IS)
Measured: from baseline to Week 26
Change in homeostatic index of beta cell function (by HOMA-BFC)
Measured: from baseline to Week 26
Change in markers of insulin sensitivity/cardiovascular risk
Measured: from baseline to Week 26
Safety: Incidence of adverse events
Measured: approximately 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871415
- Sponsor's protocol ID
- YC28036
- Status last verified
- Nov 2016
- First submitted
- 4 Jun 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF ALEGLITAZAR PLUS METFORMIN COMBINATION THERAPY COMPARED WITH PLACEBO PLUS METFORMIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS INADEQUATELY CONTROLLED WITH METFORMIN MONOTHERAPY
- ClinicalTrials.gov ID
- NCT01871415
- Acronym / sponsor ID
- YC28036
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar in combination with metformin in patients with Type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks in combination with their pre-existing metformin regimen and dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aleglitazar + metformin | Experimental | Drug: aleglitazar, Drug: metformin |
| Placebo + metformin | Active comparator | Drug: metformin, Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient, >/= 18 years of age
- Type 2 diabetes mellitus treated with stable metformin monotherapy for at least 12 weeks prior to screening; metformin dose should be >/= 1500 mg/day (or individual maximum tolerated dose), but no more than the maximum dose specified in the label
- HbA1c >/= 7% and </= 9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
- Fasting plasma glucose </= 13.3 mmol/L (</= 240 mg/dL) at pre-randomization visit
- Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study
Key exclusion criteria (18 listed)
- Pregnant women, women intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods
- Diagnosis or history of:
- Any previous treatment with thiazolidinedione or with a dual PPAR agonist
- Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (>= 1 month) statin therapy
- Prior intolerance to fibrate
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 |
|---|---|---|
| aleglitazar150 mcg orally daily | Drug | Aleglitazar + metformin |
| metforminpre-existing background regimen and dose | Drug | Aleglitazar + metformin, Placebo + metformin |
| placebomatching aleglitazar placebo orally daily | Drug | Placebo + metformin |
Primary outcome
Change in HbA1c
Time frame: from baseline to Week 26
7 secondary outcomes
Change in lipids
Time frame: from baseline to Week 26
Change in fasting plasma glucose (FPG)
Time frame: from baseline to Week 26
Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26
Time frame: 26 weeks
Change in homeostatic index of insulin sensitivity (by HOMA-IS)
Time frame: from baseline to Week 26
Change in homeostatic index of beta cell function (by HOMA-BFC)
Time frame: from baseline to Week 26
Change in markers of insulin sensitivity/cardiovascular risk
Time frame: from baseline to Week 26
Safety: Incidence of adverse events
Time frame: approximately 30 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
Related trials for Diabetes Mellitus Type 2
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.
Clinical Trials study director
Hoffmann-La Roche
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aleglitazar and metformin in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 7 sites in 2 countries.
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 5 inclusion and 18 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, South Korea. 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. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in HbA1c (time frame: from baseline to Week 26). 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 2 Nov 2016.