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A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01871415
Recruitment Status : Completed
First Posted : June 6, 2013
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: aleglitazar Drug: metformin Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2013
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Aleglitazar + metformin Drug: aleglitazar
150 mcg orally daily
Drug: metformin
pre-existing background regimen and dose
Active Comparator: Placebo + metformin Drug: metformin
pre-existing background regimen and dose
Drug: placebo
matching aleglitazar placebo orally daily

Outcome Measures

Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: from baseline to Week 26 ]

Secondary Outcome Measures :
  1. Change in lipids [ Time Frame: from baseline to Week 26 ]
  2. Change in fasting plasma glucose (FPG) [ Time Frame: from baseline to Week 26 ]
  3. Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26 [ Time Frame: 26 weeks ]
  4. Change in homeostatic index of insulin sensitivity (by HOMA-IS) [ Time Frame: from baseline to Week 26 ]
  5. Change in homeostatic index of beta cell function (by HOMA-BFC) [ Time Frame: from baseline to Week 26 ]
  6. Change in markers of insulin sensitivity/cardiovascular risk [ Time Frame: from baseline to Week 26 ]
  7. Safety: Incidence of adverse events [ Time Frame: approximately 30 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
    2. 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
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871415

Shanghai, China, 200003
ShenYang, China, 110004
Shiyan, China, 442000
Suzhou, China, 215004
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 463-712
Incheon, Korea, Republic of, 405-760
Seoul, Korea, Republic of, 150-950
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01871415     History of Changes
Other Study ID Numbers: YC28036
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs