- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01729403
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
-
-
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Neuss, Germany, 41460
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-
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
|
patients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label)
orally daily, 16 weeks
|
Experimental: Aleglitazar
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150 mcg orally daily, 16 weeks
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
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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
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22 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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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