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

NCT01729403 | Completed Phase 2

• 1 other identifier: WC28038
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Change in whole-body insulin sensitivity as assessed by M-value (Insulin-stimulated glucose disposal rate)

  from baseline to Week 16

Secondary Outcomes (11)

• Change in hepatic insulin sensitivity (basal index of hepatic insulin resistance)

  from baseline to Week 16

• Change in parameters of beta cell function (first and second phase insulin secretion)

  from baseline to Week 16

• Change in HbA1c

  from baseline to Week 16

• Change in lipid profile

  from baseline to Week 16

• Change in mean 24h blood pressure

  from baseline to Week 16

Study Arms (2)

Aleglitazar

EXPERIMENTAL

Drug: aleglitazar; Drug: metformin

Placebo

PLACEBO COMPARATOR

Drug: metformin; Drug: placebo

Interventions

aleglitazar DRUG

150 mcg orally daily, 16 weeks

Aleglitazar

metformin DRUG

patients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label)

Aleglitazar; Placebo

placebo DRUG

orally daily, 16 weeks

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

aleglitazar; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 20, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

DE (1)