NCT01871428

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

June 4, 2013

Last Update Submit

November 1, 2016

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    from baseline to Week 26

Secondary Outcomes (7)

  • Change in lipids

    from baseline to Week 26

  • Change in fasting plasma glucose (FPG)

    from baseline to Week 26

  • Responder rates, defined as target HbA1c: < 7.0%, < 6.5% at Week 26

    26 weeks

  • Change in homeostatic index of insulin sensitivity (by Homeostasis Model Assessment for Insulin Sensitivity [HOMA-IS])

    from baseline to Week 26

  • Change in homeostatic index of beta cell function (by HOMA-BFC)

    from baseline to Week 26

  • +2 more secondary outcomes

Study Arms (2)

Aleglitazar

EXPERIMENTAL
Drug: aleglitazar

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

aleglitazarDRUG

150 mcg orally daily

Aleglitazar
placeboDRUG

matching aleglitazar placebo orally daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Chongqing, 400016, China

Location

Unknown Facility

Shanghai, 200003, China

Location

Unknown Facility

Shiyan, 442000, China

Location

Unknown Facility

Suzhou, 215004, China

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Alor Star, 05400, Malaysia

Location

Unknown Facility

Perak, 33400, Malaysia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

aleglitazar

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2013

First Posted

June 6, 2013

Study Start

June 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CN(4)HK(1)MY(2)