A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Diabetes Mellitus Type 2	Drug: Placebo; Drug: aleglitazar	Phase 3

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change from baseline in hemoglobin HbA1c [ Time Frame: From baseline to week 26 ]

Secondary Outcome Measures :

1. Change in lipid profile [ Time Frame: From baseline to week 26 ]
2. Change from baseline in fasting plasma glucose [ Time Frame: From baseline to week 26 ]
3. Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%) [ Time Frame: From baseline to week 26 ]
4. Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS) [ Time Frame: From baseline to week 26 ]
5. Change from baseline in homeostatic index of beta cell function (HOMA-BCF) [ Time Frame: From baseline to week 26 ]
6. Safety: incidence of adverse events [ Time Frame: 30 weeks (26 weeks treatment and 4 weeks follow-up) ]

Eligibility Criteria

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 34 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Henry RR, Buse JB, Wu H, Durrwell L, Mingrino R, Jaekel K, El Azzouzi B, Andjelkovic M, Herz M. Efficacy, safety and tolerability of aleglitazar in patients with type 2 diabetes: pooled findings from three randomized phase III trials. Diabetes Obes Metab. 2015 Jun;17(6):560-5. doi: 10.1111/dom.12455. Epub 2015 Apr 8.

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01691755 History of Changes
Other Study ID Numbers:	BC28034
First Posted:	September 25, 2012
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