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A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01691755
First received: September 20, 2012
Last updated: August 9, 2016
Last verified: August 2016
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Purpose
This multicenter, randomized, double-blind, placebo-controlled study will assess the efficacy, safety and tolerability of aleglitazar monotherapy compared with placebo in patients with type 2 diabetes mellitus who have not previously received anti-hyperglycemic therapy. Patients will be randomized to receive oral doses of 150 mcg aleglitazar once daily or placebo. The anticipated time on study treatment is 26 weeks.
| Condition | Intervention | Phase |
|---|---|---|
| Diabetes Mellitus Type 2 | Drug: Placebo Drug: aleglitazar | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, 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 Anti-Hyperglycemic Therapy |
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Change from baseline in hemoglobin HbA1c [ Time Frame: From baseline to week 26 ]
Secondary Outcome Measures:
- Change in lipid profile [ Time Frame: From baseline to week 26 ]
- Change from baseline in fasting plasma glucose [ Time Frame: From baseline to week 26 ]
- Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%) [ Time Frame: From baseline to week 26 ]
- Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS) [ Time Frame: From baseline to week 26 ]
- Change from baseline in homeostatic index of beta cell function (HOMA-BCF) [ Time Frame: From baseline to week 26 ]
- Safety: incidence of adverse events [ Time Frame: 30 weeks (26 weeks treatment and 4 weeks follow-up) ]
| Enrollment: | 196 |
| Study Start Date: | November 2012 |
| Study Completion Date: | September 2013 |
| Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo
oral doses once a day for 26 weeks
|
| Experimental: aleglitazar |
Drug: aleglitazar
150 mcg orally once a day for 26 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Diagnosis of diabetes mellitus, type 2 within 12 months prior to screening
- Patients who have not received a anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months 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 </=240 mg/dL at pre-randomization visit
- Agreement to maintain diet and exercise habits during the study
Exclusion Criteria:
- Patients with Type 1 diabetes mellitus, secondary diabetes, diabetes resulting from pancreatic injury, or acute metabolic diabetic complications within the past 6 months
- Any previous treatment with thiazolidinedione or a dual peroxisome proliferator activated receptor (PPAR) agonist
- Any body weight lowering or lipoprotein-modifying therapy within 12 weeks prior to screening (except stable dose of statin)
- Symptomatic congestive heart failure classified as New York Heart Association class II-IV at screening
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01691755
Show 34 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691755
Show 34 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01691755 History of Changes |
| Other Study ID Numbers: |
BC28034 |
| Study First Received: | September 20, 2012 |
| Last Updated: | August 9, 2016 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 21, 2017