A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy

Tracking Information
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; (submitted: June 4, 2013)	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; (submitted: August 9, 2016)	Change in lipids [ Time Frame: from baseline to Week 26 ]; Change in fasting plasma glucose (FPG) [ Time Frame: from baseline to Week 26 ]; Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26 [ Time Frame: 26 weeks ]; Change in homeostatic index of insulin sensitivity (by Homeostasis Model Assessment for Insulin Sensitivity [HOMA-IS]) [ Time Frame: from baseline to Week 26 ]; Change in homeostatic index of beta cell function (by HOMA-BFC) [ Time Frame: from baseline to Week 26 ]; Change in markers of insulin sensitivity/cardiovascular risk [ Time Frame: from baseline to Week 26 ]; Safety: Incidence of adverse events [ Time Frame: approximately 30 weeks ]
Original Secondary Outcome Measures ICMJE; (submitted: June 4, 2013)	Change in lipids [ Time Frame: from baseline to Week 26 ]; Change in fasting plasma glucose (FPG) [ Time Frame: from baseline to Week 26 ]; Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26 [ Time Frame: 26 weeks ]; Change in homeostatic index of insulin sensitivity (by HOMA-IS) [ Time Frame: from baseline to Week 26 ]; Change in homeostatic index of beta cell function (by HOMA-BFC) [ Time Frame: from baseline to Week 26 ]; Change in markers of insulin sensitivity/cardiovascular risk [ Time Frame: from baseline to Week 26 ]; Safety: Incidence of adverse events [ Time Frame: approximately 30 weeks ]
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
Condition ICMJE	Diabetes Mellitus Type 2
Intervention ICMJE	Drug: aleglitazar 150 mcg orally daily; Drug: placebo matching aleglitazar placebo orally daily
Study Arms	Experimental: Aleglitazar Intervention: Drug: aleglitazar; Placebo Comparator: Placebo Intervention: Drug: placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 18, 2013)	13
Original Estimated Enrollment ICMJE; (submitted: June 4, 2013)	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: Adult patient, >/= 18 years of age; Diagnosis of Type 2 diabetes mellitus within 12 months prior to screening; Drug-naïve (defined as no anti-hyperglycemic medication for at least 12 weeks prior to screening and for not longer than 3 consecutive months at any time 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 </= 13.3 mmol/L (</= 240 mg/dL) at pre-randomization visit; Agreement to maintain diet and exercise habits implemented during the run-in phase during the full course of the study Exclusion Criteria: Pregnant women, women intending to become pregnant during the study period, currently lactating women, or women of child-bearing potential not using highly effective, medically approved birth control methods; Diagnosis or history of: Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months; Any previous treatment with thiazolidinedione or with a dual peroxisome proliferator activated receptor (PPAR) agonist; Any body weight lowering or lipoprotein-modifying therapy (e.g. fibrates) within 12 weeks prior to screening with the exception of stable (>= 1 month) statin therapy; Prior intolerance to fibrate; Triglycerides (fasting) > 4.5 mmol/L (> 400 mg/dL) at screening or within 4 weeks prior to screening; Clinically apparent liver disease; Anemia at or within 4 weeks prior to screening; Inadequate renal function; Symptomatic congestive heart failure New York Heart Association (NYHA) Class II-IV at screening; Myocardial infarction, acute coronary syndrome or transient ischemic attack/stroke within 6 months prior to screening visit; Known macular edema at screening or prior to screening visit; Diagnosed and/or treated malignancy (except for basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years; Uncontrolled hypertension; History of active substance abuse (including alcohol) within the past 2 years
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Study Director: Clinical Trials Hoffmann-La Roche
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