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

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
aleglitazar
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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

aleglitazar

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in hemoglobin HbA1c

Secondary Outcome Measures

Change in lipid profile
Change from baseline in fasting plasma glucose
Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%)
Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)
Change from baseline in homeostatic index of beta cell function (HOMA-BCF)
Safety: incidence of adverse events

Full Information

First Posted
September 20, 2012
Last Updated
August 9, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01691755
Brief Title
A Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus Who Have Not Previously Received Anti-Hyperglycemic Therapy
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 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 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.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
aleglitazar
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral doses once a day for 26 weeks
Intervention Type
Drug
Intervention Name(s)
aleglitazar
Intervention Description
150 mcg orally once a day for 26 weeks
Primary Outcome Measure Information:
Title
Change from baseline in hemoglobin HbA1c
Time Frame
From baseline to week 26
Secondary Outcome Measure Information:
Title
Change in lipid profile
Time Frame
From baseline to week 26
Title
Change from baseline in fasting plasma glucose
Time Frame
From baseline to week 26
Title
Responder rate as defined of hemoglobin A1c (HbAc1) <7.0% (<6.5%)
Time Frame
From baseline to week 26
Title
Change from baseline in homeostatic index of insulin sensitivity (HOMA-IS)
Time Frame
From baseline to week 26
Title
Change from baseline in homeostatic index of beta cell function (HOMA-BCF)
Time Frame
From baseline to week 26
Title
Safety: incidence of adverse events
Time Frame
30 weeks (26 weeks treatment and 4 weeks follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
City
Cooper City
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
City
St Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37919
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
City
Aguascaliente
ZIP/Postal Code
20230
Country
Mexico
City
Cuernavaca
ZIP/Postal Code
62250
Country
Mexico
City
Culiacan
ZIP/Postal Code
80020
Country
Mexico
City
Durango
ZIP/Postal Code
34000
Country
Mexico
City
Durango
ZIP/Postal Code
34080
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
City
Mexico City
ZIP/Postal Code
11650
Country
Mexico
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
City
Pachuca
ZIP/Postal Code
42090
Country
Mexico
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
City
Tampico
ZIP/Postal Code
89000
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
25728612
Citation
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):560-565. doi: 10.1111/dom.12455. Epub 2015 Apr 8.
Results Reference
derived

Learn more about this trial

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

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