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

Diabetes Mellitus Type 2 Clinical Trial

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 T2D Inadequately Controlled With Metformin Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691846
• Other study ID #: BC28035
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2012
• Last updated: February 22, 2017
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: February 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• aleglitazar+metformin
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
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hemoglobin HbA1c		From baseline to week 26
Secondary	Change in lipid profile		From baseline to week 26
Secondary	Change from baseline in fasting plasma glucose		From baseline to week 26
Secondary	Responder rate as defined of hemoglobin HbAc1 <7.0% (<6.5%)		From baseline to week 26
Secondary	Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)		From baseline to week 26
Secondary	Change from baseline in homeostatic index of beta cell function (HOMA-BCF)		From baseline to week 26
Secondary	Safety: incidence of adverse events		30 weeks (26 weeks treatment and 4 weeks follow-up)