A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin

November 1, 2016 updated by: Hoffmann-La Roche

A Single Centre, Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus (T2D) Who Are Inadequately Controlled With Metformin Monotherapy

This single-center, randomized, double-blind, placebo-controlled study will evaluate the effect of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus who are inadequately controlled on metformin monotherapy. Patients will be randomized to receive either aleglitazar 150 mcg or placebo orally daily for 16 weeks, in addition to their existing dose and regimen of metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, 30 to 70 years of age inclusive at screening
  • Type 2 diabetes mellitus patients treated with stable metformin therapy for at least 12 weeks prior to screening; metformin dose should not exceed the maximum dose specified in the label
  • HbA1c >/= 6.5% and </= 9% at screening and baseline
  • Fasting plasma glucose </= 13.3 mmol/L (</= 240 mg/dl) at screening and baseline
  • Body mass index (BMI) >/= 25 at screening; BMI >/= 27 for subjects with HbA1c < 7%
  • Stable weight +/- 5% for at least 12 weeks prior to screening

Exclusion Criteria:

  • Women who are pregnant, 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 type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
  • Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months
  • Any previous treatment with a 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
  • History of bariatric surgery or currently undergoing evaluation for bariatric surgery
  • Prior intolerance to fibrate
  • Treatment with any anti-diabetic medication other than metformin in the last 12 weeks prior to screening and/or herbal/over-the-counter preparations that may affect glycemic control within 12 weeks prior to screening
  • Clinically apparent liver disease
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Clinical evidence of anemia
  • Symptomatic congestive heart failure (New York Heart Association Class II-IV) at screening
  • Myocardial infarction, acute coronary syndrome, or transient ischemic attack/stroke within 6 months prior to screening
  • Known macular edema at screening or prior to screening visit
  • Uncontrolled hypertension despite stable (for at least 4 weeks) anti-hypertensive treatment
  • Diagnosed and/or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix or in situ prostate cancer) within the past 5 years
  • Chronic oral or parenteral corticosteroid treatment (> 2 weeks) within 3 months prior to screening
  • History of active substance abuse (including alcohol) within the past 2 years or positive test result for drugs of abuse or alcohol prior to first dosing
  • Presence of any absolute or relative contraindication for the conduct of magnetic resonance imaging (MRI) investigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: metformin
patients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label)
Drug: placebo
orally daily, 16 weeks
Experimental: Aleglitazar
Drug: aleglitazar
150 mcg orally daily, 16 weeks
Drug: metformin
patients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in whole-body insulin sensitivity as assessed by M-value (Insulin-stimulated glucose disposal rate)
Time Frame: from baseline to Week 16
from baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in hepatic insulin sensitivity (basal index of hepatic insulin resistance)
Time Frame: from baseline to Week 16
from baseline to Week 16
Change in parameters of beta cell function (first and second phase insulin secretion)
Time Frame: from baseline to Week 16
from baseline to Week 16
Change in HbA1c
Time Frame: from baseline to Week 16
from baseline to Week 16
Change in lipid profile
Time Frame: from baseline to Week 16
from baseline to Week 16
Change in mean 24h blood pressure
Time Frame: from baseline to Week 16
from baseline to Week 16
Change in hepatic fat content measured by magnetic resonance spectroscopy (MRI)
Time Frame: from baseline to Week 16
from baseline to Week 16
Change in fat content/distribution in the abdominal region measured by MRI
Time Frame: from baseline to Week 16
from baseline to Week 16
Change in total body fat content measured by air displacement phlethysmography
Time Frame: from baseline to Week 16
from baseline to Week 16
Change in homeostatic indexes of insulin sensitivity assessed by Homeostasis Model Assessment for Insulin Sensitivity (HOMA-IS)
Time Frame: from baseline to Week 16
from baseline to Week 16
Change in markers of cardiovascular risk (high sensitivity C-reactive protein, adiponectin, free fatty acid)
Time Frame: from baseline to Week 16
from baseline to Week 16
Safety: Incidence of adverse events
Time Frame: 22 weeks
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WC28038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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