A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy

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 Monotherapy Compared With Placebo in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Drug-Naïve to Anti-Hyperglycemic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691755
• Other study ID #: BC28034
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2012
• Last updated: August 9, 2016
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: August 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. 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: 196
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening

• Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months in the past

• 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 peroxisome proliferator activated receptor (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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Placebo
oral doses once a day for 26 weeks
• aleglitazar
150 mcg orally once a day for 26 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in hemoglobin HbA1c		From baseline to week 26	No
Secondary	Change in lipid profile		From baseline to week 26	No
Secondary	Change from baseline in fasting plasma glucose		From baseline to week 26	No
Secondary	Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%)		From baseline to week 26	No
Secondary	Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)		From baseline to week 26	No
Secondary	Change from baseline in homeostatic index of beta cell function (HOMA-BCF)		From baseline to week 26	No
Secondary	Safety: incidence of adverse events		30 weeks (26 weeks treatment and 4 weeks follow-up)	No