Efficacy of Pioglitazone and Fortamet Combination Therapy in Subjects With Type 2 Diabetes

NCT00754403 | Completed Phase 4

• 2 other identifiers: 01-05-TL-OPIXT-010U1111-1114-2423
• Study Type: interventional
• Target: 312
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the efficacy of pioglitazone and metformin combination therapy, once daily (QD), on glycosylated hemoglobin in adults with type 2 diabetes.

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change from randomization in Glycosylated Hemoglobin

  Final Visit

Secondary Outcomes (11)

• Change from randomization in Fasting Plasma Glucose

  Final Visit

• Change from randomization in Insulin

  Final Visit

• Change from randomization in Pro-Insulin

  Final Visit

• Change from randomization in Homeostasis Model Assessment

  Final Visit

• Change from randomization in Triglycerides

  Final Visit

Study Arms (2)

Pioglitazone 30 mg QD + Metformin 1000 mg QD

EXPERIMENTAL

Drug: Pioglitazone and metformin

Metformin 1000 mg QD

ACTIVE COMPARATOR

Drug: Metformin

Interventions

Pioglitazone and metformin DRUG

Pioglitazone 30 mg, tablets, orally, once daily and metformin 1000 mg, tablets, orally once daily for up to 16 weeks.

Also known as: Actos, AD-4833XT, Fortamet

Pioglitazone 30 mg QD + Metformin 1000 mg QD

Metformin DRUG

Pioglitazone placebo-matching tablets, orally, once daily and metformin 1000 mg, tablets, orally once daily for up to 16 weeks.

Also known as: Fortamet

Metformin 1000 mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Diagnosed with type 2 diabetes and must have received appropriate counseling on lifestyle modification for type 2 diabetes including diet and exercise.
• If taking metformin monotherapy or metformin and sulfonylurea combination therapy, has a glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 9.0% at screening and randomization.
• If naïve or taking sulfonylurea monotherapy has an glycosylated hemoglobin greater than or equal to 8.5% and less than or equal to 10.0% at screening and greater than or equal to 7.5% and less than or equal to 9.0% at randomization.

You may not qualify if:

• Has type 1 diabetes mellitus
• Currently taking any thiazolidinedione or have taken any thiazolidinedione within 12 weeks prior to screening
• Has congestive heart failure; has a triglyceride level greater than 500 mg per dL
• Diastolic blood pressure greater than 100 mmHg or a systolic pressure greater than 160 mmHg
• Body mass index greater than or equal to 42 kg/m2 (weight /height2)
• Alanine transaminase level greater than or equal to 2.5 times the upper limit of normal, active liver disease, or jaundice.
• Male subjects who have a serum creatinine level greater than or equal to 1.5 mg per dL; female subjects who have a serum creatinine level greater than or equal to 1.4 mg per dL at the screening visit and at randomization.
• Currently using insulin or has used insulin 3 months prior to Screening
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.
• 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:
• Chronically used oral or parenteral glucocorticoids (eg, prednisone, cortisone, hydrocortisone, dexamethasone)
• Niacin greater than 200 mg per day, including niacin-containing products such as Advicor - 3 months prior to screening and during the study
• Chronically used steroid-joint injections - 3 months prior to screening and during the study
• Thiazolidinediones - 3 months prior to screening and during the study
• Insulin - 3 months prior to screening

Sponsors & Collaborators

• Takeda: lead

Related Links

• ACTOS® Package Insert

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus, Lipoatrophic; Dyslipidemias

Interventions

Pioglitazone; Metformin

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines

Study Officials

• VP Clinical Science Strategy

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: September 17, 2008
• First Posted: September 18, 2008
• Study Start: July 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: July 5, 2010

Record last verified: 2010-07