Efficacy of Pioglitazone and Insulin in Treating Subjects With Type 2 Diabetes Mellitus and Renal Failure.

NCT00770640 | Completed Phase 2

• 4 other identifiers: ATS K0292007-006744-21DE-PIO-029U1111-1114-1645
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to determine the metabolic and cardiovascular effects of pioglitazone, once daily (QD), and insulin combination therapy in subjects with Type 2 Diabetes and Renal Failure.

Conditions

Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change of total daily Insulin Dose.

  Week 24 or Final Visit.

Secondary Outcomes (24)

• Individual insulin doses to assess the number of patients with insulin reduction of greater than or equal to 30%.

  Weeks 12 and 24 or Final Visit.

• Change from Baseline in Glycosylated Hemoglobin.

  Weeks 12 and 24 or Final Visit.

• Change from Baseline in Glucose.

  Weeks 12 and 24 or Final Visit.

• Change from Baseline in Insulin.

  Weeks 12 and 24 or Final Visit.

• Change from Baseline in C-peptide.

  Weeks 12 and 24 or Final Visit.

Study Arms (2)

Pioglitazone 30mg QD

EXPERIMENTAL

(and variable insulin therapy)

Drug: Pioglitazone and insulin

Placebo QD

PLACEBO COMPARATOR

(and variable insulin therapy)

Drug: Insulin

Interventions

Pioglitazone and insulin DRUG

Pioglitazone 30 mg, tablets, orally, once daily and variable insulin therapy for up to 24 weeks.

Also known as: ACTOS®, AD-4833

Pioglitazone 30mg QD

Insulin DRUG

Pioglitazone placebo-matching tablets, orally, once daily and variable insulin therapy for up to 24 weeks.

Placebo QD

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has Type 2 Diabetes Mellitus, and is a patient on insulin treatment for at least 3 months.
• Has a body mass index less than 36 kg/m²
• Has a glycosylated hemoglobin level greater than or equal to 6.0% and less than 10%.
• Patient is on hemo-dialysis with or without residual excretion
• An insulin dose greater than 20 IE/day

You may not qualify if:

• Has a history of type 1 diabetes.
• Has acute infections.
• History of hypersensitivity to the study drugs or to drugs with similar chemical structures.
• History of severe or multiple allergies.
• Has a progressive fatal disease other than kidney failure.
• Has a history of drug or alcohol abuse within the last 5 years.
• A history of significant cardiovascular (e.g. Coronary heart failure based on New York Heart Association stage III - IV), respiratory, gastrointestinal, hepatic (e.g. alanine aminotransferase greater than 2.5 times the normal reference range) or hematological disease.
• History of primary hyperaldosteronism
• Acute myocardial infarction, open heart surgery or cerebral event (stroke/transient ischemic attack) within the last year prior to study start.
• Any further antidiabetic treatment except pioglitazone and insulin.
• History of macular edema.
• 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:
• Treatment with any other investigational drug within 3 months before trial entry.
• Treatment with steroids within 3 months before trial entry.
• Treatment with thiazolidinediones within the past 3 months.

Sponsors & Collaborators

• Takeda: lead

Study Sites (9)

Unknown Facility

Schwetzingen, Baden-Wurttemberg, Germany

Location

Unknown Facility

Wiesbaden, Hesse, Germany

Location

Unknown Facility

Bottrop, North Rhine-Westphalia, Germany

Location

Unknown Facility

Düsseldorf, North Rhine-Westphalia, Germany

Location

Unknown Facility

Lüdenscheid, North Rhine-Westphalia, Germany

Location

Unknown Facility

Solingen, North Rhine-Westphalia, Germany

Location

Unknown Facility

Alzey, Rhineland-Palatinate, Germany

Location

Unknown Facility

Ingelheim, Rhineland-Palatinate, Germany

Location

Unknown Facility

Mainz, Rhineland-Palatinate, Germany

Location

Related Links

• ACTOS® Package Insert

MeSH Terms

Conditions

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

Interventions

Pioglitazone; Insulin

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; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Director

  Takeda Pharma GmbH, Aachen (Germany)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: August 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 1, 2010

Record last verified: 2010-08

Locations

DE (9)