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

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Roche

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: placebo+metformin
Drug: aleglitazar+metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01691846
BC28035

Details and patient eligibility

About

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar plus metformin combination therapy compared with placebo plus metformin in patients with type 2 diabetes mellitus who are inadequately controlled with metformin monotherapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients, >/=18 years of age
  • Diagnosis of diabetes mellitus type 2
  • Patients treated with stable metformin monotherapy for at least 12 weeks prior to screening
  • HbA1c >/=7% and </=9.5% at screening or within 4 weeks prior to screening and at pre-randomization visit
  • Fasting plasma glucose </=240 mg/dL at pre-randomization visit
  • Agreement to maintain diet and exercise habits during the study

Exclusion criteria

  • Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
  • Any previous treatment with thiazolidinedione or a dual PPAR agonist
  • Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
  • Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups, including a placebo group

aleglitazar
Experimental group
Treatment:
Drug: aleglitazar+metformin
placebo
Placebo Comparator group
Treatment:
Drug: placebo+metformin

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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