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

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
aleglitazar
metformin
placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aleglitazar

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2012
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01729403
Brief Title
A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aleglitazar
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
aleglitazar
Intervention Description
150 mcg orally daily, 16 weeks
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
patients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
orally daily, 16 weeks
Primary Outcome Measure Information:
Title
Change in whole-body insulin sensitivity as assessed by M-value (Insulin-stimulated glucose disposal rate)
Time Frame
from baseline to Week 16
Secondary Outcome Measure Information:
Title
Change in hepatic insulin sensitivity (basal index of hepatic insulin resistance)
Time Frame
from baseline to Week 16
Title
Change in parameters of beta cell function (first and second phase insulin secretion)
Time Frame
from baseline to Week 16
Title
Change in HbA1c
Time Frame
from baseline to Week 16
Title
Change in lipid profile
Time Frame
from baseline to Week 16
Title
Change in mean 24h blood pressure
Time Frame
from baseline to Week 16
Title
Change in hepatic fat content measured by magnetic resonance spectroscopy (MRI)
Time Frame
from baseline to Week 16
Title
Change in fat content/distribution in the abdominal region measured by MRI
Time Frame
from baseline to Week 16
Title
Change in total body fat content measured by air displacement phlethysmography
Time Frame
from baseline to Week 16
Title
Change in homeostatic indexes of insulin sensitivity assessed by Homeostasis Model Assessment for Insulin Sensitivity (HOMA-IS)
Time Frame
from baseline to Week 16
Title
Change in markers of cardiovascular risk (high sensitivity C-reactive protein, adiponectin, free fatty acid)
Time Frame
from baseline to Week 16
Title
Safety: Incidence of adverse events
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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