NCT00770952

Brief Summary

The purpose of this study is to determine the effect of pioglitazone, once daily (QD), and glimepiride combination therapy compared to glimepiride monotherapy in subjects with Type 2 Diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at below P25 for phase_3 diabetes-mellitus

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

17 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

December 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 5, 2010

Status Verified

July 1, 2010

Enrollment Period

2 years

First QC Date

October 9, 2008

Last Update Submit

July 1, 2010

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism DisorderDysmetabolic SyndromeType II DiabetesDiabetes Mellitus, LipoatrophicDyslipidemiaDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Homeostatic Model Assessment - Beta cell.

    Week: 24 or Final Visit beyond week 12.

Secondary Outcomes (12)

  • Change from Baseline in Glycosylated Hemoglobin.

    Week: 24 or Final Visit beyond week 12.

  • Change from Baseline in oral glucose tolerance testing.

    Week: 24 or Final Visit beyond week 12.

  • Change from Baseline in Insulin.

    Week: 24 or Final Visit beyond week 12.

  • Change from Baseline in Proinsulin.

    Week: 24 or Final Visit beyond week 12.

  • Change from Baseline in C-peptide.

    Week: 24 or Final Visit beyond week 12.

  • +7 more secondary outcomes

Study Arms (2)

Pioglitazone 30 mg to 45 mg QD + Glimepiride 2 mg to 4 mg QD

EXPERIMENTAL
Drug: Pioglitazone and Glimepiride

Glimepiride 4 mg to 6 mg QD

ACTIVE COMPARATOR
Drug: Glimepiride

Interventions

Pioglitazone and GlimepirideDRUG

Pioglitazone 30 mg, tablets, orally, once daily and Glimepiride 2 mg, tablets, orally once daily for two weeks; increased to: Pioglitazone 30 mg, tablets, orally, once daily and Glimepiride 4 mg, tablets, orally, once daily for two weeks; increased to: Pioglitazone 45 mg, tablets, orally, once daily and Glimepiride 4 mg, orally, once daily for up to 20 weeks.

Also known as: ACTOS®
Pioglitazone 30 mg to 45 mg QD + Glimepiride 2 mg to 4 mg QD
GlimepirideDRUG

Pioglitazone placebo-matching tablets, orally, once daily and Glimepiride 4 mg, tablets, orally once daily for two weeks; increased to: Pioglitazone placebo-matching tablets, orally, once daily and Glimepiride 5 mg, tablets, orally once daily for two weeks; increased to: Pioglitazone placebo-matching tablets, orally, once daily and Glimepiride 6 mg, tablets, orally once daily for up to 20 weeks.

Glimepiride 4 mg to 6 mg QD

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes according to the American Diabetes Association Criteria.
  • Treatment with Glimepiride monotherapy (1-3 mg per day) 3 months before entering the study.
  • Glycosylated hemoglobin greater than 6.5%, but less than 8.5% and/ or fasting plasma glucose greater than 7 mmol/l within the last 4 weeks.
  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

You may not qualify if:

  • Type 1 Diabetes mellitus.
  • History of hypersensitivity to the study drugs or to drugs with similar chemical structures.
  • Progressive fatal disease.
  • History of drug or alcohol abuse during the last 5 years.
  • More than one unexplained episode of severe hypoglycemia within 6 months prior to entering the study.
  • A history of significant cardiovascular (New York Heart Association stage I - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase greater than 2.5 times the upper limit of the normal reference range), renal (serum creatinine greater than 1.8 mg/dl; glomerular filtration rate less than 40 ml/min as estimated by the Cockroft-Gault formula), neurological, psychiatric and/or hematological disease, history of macular edema.
  • Blood donation within the last 30 days.
  • Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
  • CYP2C9 inductors
  • CYP2C9 inhibitors
  • rifampicin
  • fluconazole
  • drugs used for treating type 2 diabetes (insulin, insulin analogous compounds and oral antidiabetic drugs)
  • Pretreatment with thiazolidinediones within the last 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Location

Unknown Facility

Aschaffenburg, Bavaria, Germany

Location

Unknown Facility

Ingolstadt, Bavaria, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, Germany

Location

Unknown Facility

Frielendorf, Hesse, Germany

Location

Unknown Facility

Rotenburg an der Fulda, Hesse, Germany

Location

Unknown Facility

Hanover, Lower Saxony, Germany

Location

Unknown Facility

Dortmund, North Rhine-Westphalia, Germany

Location

Unknown Facility

Siegen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Kallstadt, Rhineland-Palatinate, Germany

Location

Unknown Facility

Mainz, Rhineland-Palatinate, Germany

Location

Unknown Facility

Mayen, Rhineland-Palatinate, Germany

Location

Unknown Facility

Neuwied, Rhineland-Palatinate, Germany

Location

Unknown Facility

Rhaunen, Rhineland-Palatinate, Germany

Location

Unknown Facility

Friedrichsthal, Saarland, Germany

Location

Unknown Facility

Meissen, Saxony, Germany

Location

Unknown Facility

Berlin, State of Berlin, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusGlucose Metabolism DisordersDiabetes Mellitus, Type 2Diabetes Mellitus, LipoatrophicDyslipidemias

Interventions

Pioglitazoneglimepiride

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Medical Adviser Clinical Research

    Takeda Pharma Gmbh, Aachen (Germany)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

December 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 5, 2010

Record last verified: 2010-07

Locations

DE(17)