A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy
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ClinicalTrials.gov Identifier: NCT01871428 |
Recruitment Status
:
Completed
First Posted
: June 6, 2013
Last Update Posted
: November 2, 2016
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
Tracking Information | ||||
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First Submitted Date ICMJE | June 4, 2013 | |||
First Posted Date ICMJE | June 6, 2013 | |||
Last Update Posted Date | November 2, 2016 | |||
Study Start Date ICMJE | June 2013 | |||
Actual Primary Completion Date | November 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in HbA1c [ Time Frame: from baseline to Week 26 ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01871428 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy | |||
Official Title ICMJE | A Multicenter, Randomized, Doubleblind, 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 Antihyperglycemic Therapy | |||
Brief Summary | This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes mellitus who are drug-naïve to anti-hyperglycemic therapy. Patients will be randomized to receive either aleglitazar 150 mcg orally daily or placebo for 26 weeks. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Diabetes Mellitus Type 2 | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
13 | |||
Original Estimated Enrollment ICMJE |
400 | |||
Actual Study Completion Date | November 2013 | |||
Actual Primary Completion Date | November 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China, Hong Kong, Malaysia | |||
Removed Location Countries | Philippines, Taiwan | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01871428 | |||
Other Study ID Numbers ICMJE | YC28037 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Hoffmann-La Roche | |||
Study Sponsor ICMJE | Hoffmann-La Roche | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Hoffmann-La Roche | |||
Verification Date | November 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |