A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy
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ClinicalTrials.gov Identifier: NCT01691755 |
Recruitment Status
:
Completed
First Posted
: September 25, 2012
Last Update Posted
: August 11, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus Type 2 | Drug: Placebo Drug: aleglitazar | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 196 participants |
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 |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | September 2013 |
Actual Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
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
|
- Change from baseline in hemoglobin HbA1c [ Time Frame: From baseline to week 26 ]
- 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) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691755

Study Director: | Clinical Trials | Hoffmann-La Roche |
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 |
First Posted: | September 25, 2012 Key Record Dates |
Last Update Posted: | August 11, 2016 |
Last Verified: | August 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 |