Effect of Acute Insulin Intervention followed by Pioglitazone and Metformin Treatment on Metabolic Parameters in Type 2 Diabetic Patients with inadequate Metabolic Control

• Conditions: Diabetes Type 2

• Registration Number: EUCTR2006-002354-30-DE
• Lead Sponsor: Takeda Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Type 2 diabetes according to the ADA Criteria
2.Treatment with oral antidiabetic agents except PPAR?- agonists
3.Age 30-75 years
4.Fasting C-Peptide levels > 2 ng/mL
5.HbA1c >= 6.5%
6.more than 2 blood glucose measurements >200 mg/dL within the last two weeks

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Type 1 diabetes mellitus
2.History of ketoacidosis or lactic acidosis
3.Use of systemic corticosteroids within the last 3 months prior to screening visit
4.Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
5.History of severe or multiple allergies
6.Treatment with any other investigational drug within 3 months before trial entry.
7.Have had more than one unexplained episode of severe hypoglycaemia (defined as requiring assistance of another person due to disabling hypo¬glycaemia) within 6 months prior to screening visit
8.Progressive fatal disease
9.History of drug or alcohol abuse within the last 5 years prior to study participation
10.A history of significant cardiovascular ( NYHA stage II - IV), respiratory, gastrointestinal, hepatic (ALAT > 2.5 times the normal reference range), renal (creatinine > 1.1 mg/dL in women and > 1.5 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator.
11.Blood donation within the last 30 days
12.Pregnancy or breast feeding
13.Sexually active women of childbearing age not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomised partner.
14.Lack of compliance or other similar reason, that, the investigator believes, precludes satisfactory participation in the study

15.Pre-treatment with PPAR? agonists within the 3 months prior to screening
16.Respiratory insufficiency
17.Myocardial infarction within 6 months prior to screening visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study will investigate the effect of acute intervention with insulin for 2 days and subsequent oral treatment with pioglitazone and metformin in type 2 diabetic patients, inadequately controlled with prior oral antidiabetic agents;Secondary Objective: To investigate the effect of acute insulin intervention with subsequent Pioglitazone and Metformin treatment on various laboratory parameters;Primary end point(s): The primary endpoint of the study is to evaluate the percentage of patients who remain stable on oral therapy as defined by an improvement in HbA1c of at least 0.5% within 4 months.