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Completed

NCT Number: NCT01691846

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

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aleglitazar+metformin

Drug

150 mcg aleglitazar given orally once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)

placebo+metformin

Drug

Oral doses of matching placebo once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)

Primary outcomes

  1. Change from baseline in hemoglobin HbA1c

    Time frame: From baseline to week 26

Secondary outcomes

  1. Change in lipid profile

    Time frame: From baseline to week 26

  2. Change from baseline in fasting plasma glucose

    Time frame: From baseline to week 26

  3. Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%)

    Time frame: From baseline to week 26

  4. Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)

    Time frame: From baseline to week 26

  5. Change from baseline in homeostatic index of beta cell function (HOMA-BCF)

    Time frame: From baseline to week 26

  6. Safety: incidence of adverse events

    Time frame: 30 weeks (26 weeks treatment and 4 weeks follow-up)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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 T2D Inadequately Controlled With Metformin Monotherapy

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 25, 2012
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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