A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Multicenter, Randomized, Doubleblind, 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 Antihyperglycemic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871428
• Other study ID #: YC28037
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2013
• Last updated: November 1, 2016
• Start date: June 2013
• Est. completion date: November 2013

Study information

• Verified date: November 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 evaluate the efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patient, >/= 18 years of age

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

• Drug-naïve (defined as no anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months at any time 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 </= 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

Exclusion Criteria:

• 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:

1. Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes

2. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months

• Any previous treatment with thiazolidinedione or with a dual peroxisome proliferator activated receptor (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

• 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 New York Heart Association (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

• Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years

• Uncontrolled hypertension

• History of active substance abuse (including alcohol) within the past 2 years

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:
• aleglitazar
150 mcg orally daily
• placebo
matching aleglitazar placebo orally daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

China,  Hong Kong,  Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c		from baseline to Week 26	No
Secondary	Change in lipids		from baseline to Week 26	No
Secondary	Change in fasting plasma glucose (FPG)		from baseline to Week 26	No
Secondary	Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26		26 weeks	No
Secondary	Change in homeostatic index of insulin sensitivity (by Homeostasis Model Assessment for Insulin Sensitivity [HOMA-IS])		from baseline to Week 26	No
Secondary	Change in homeostatic index of beta cell function (by HOMA-BFC)		from baseline to Week 26	No
Secondary	Change in markers of insulin sensitivity/cardiovascular risk		from baseline to Week 26	No
Secondary	Safety: Incidence of adverse events		approximately 30 weeks	No