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

NCT01871415 | Completed Phase 3

• 1 other identifier: YC28036
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 7

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  from baseline to Week 26

Secondary Outcomes (7)

• Change in lipids

  from baseline to Week 26

• Change in fasting plasma glucose (FPG)

  from baseline to Week 26

• Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26

  26 weeks

• Change in homeostatic index of insulin sensitivity (by HOMA-IS)

  from baseline to Week 26

• Change in homeostatic index of beta cell function (by HOMA-BFC)

  from baseline to Week 26

Study Arms (2)

Aleglitazar + metformin

EXPERIMENTAL

Drug: aleglitazar; Drug: metformin

Placebo + metformin

ACTIVE COMPARATOR

Drug: metformin; Drug: placebo

Interventions

aleglitazar DRUG

150 mcg orally daily

Aleglitazar + metformin

metformin DRUG

pre-existing background regimen and dose

Aleglitazar + metformin; Placebo + metformin

placebo DRUG

matching aleglitazar placebo orally daily

Placebo + metformin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Unknown Facility

Shanghai, 200003, China

Location

Unknown Facility

Shenyang, 110004, China

Location

Unknown Facility

Shiyan, 442000, China

Location

Unknown Facility

Suzhou, 215004, China

Location

Unknown Facility

Gyeonggi-do, 463-712, South Korea

Location

Unknown Facility

Incheon, 405-760, South Korea

Location

Unknown Facility

Seoul, 150-950, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

aleglitazar; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

KR (3); CN (4)