Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin
Overview[ - collapse ][ - ]
Purpose | The aim of the study is to show that treatment with Glargine will lead to an improvement in beta cell function especially within times of maximal beta cell stress occurring after a meal. For this reason three different standardized test meals (breakfast, lunch, dinner) will be performed and the postprandial secretion of intact proinsulin levels will be measured. These measurements will be performed with patients treated in combination with metformin and insulin glargine versus metformin plus NPH insulin (within the core study) and if significant difference is observed, with a third treatment arm with metformin plus insulin detemir. Hypothesis is that the area under the curve (AUC) intact proinsulin levels within 2 hours after test meal dinner of metformin plus insulin glargin differs from AUC intact proinsulin levels of metformin plus NPH insulin. |
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Condition | Type 2 Diabetic Patients Insufficient Metabolic Control OAD Treatment |
Intervention | Drug: Insulin Glargin Drug: NPH insulin Drug: Insulin detemir Drug: metformin |
Phase | Phase 4 |
Sponsor | ikfe-CRO GmbH |
Responsible Party | ikfe-CRO GmbH |
ClinicalTrials.gov Identifier | NCT00941148 |
First Received | July 16, 2009 |
Last Updated | July 16, 2009 |
Last verified | July 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | July 16, 2009 |
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Last Updated Date | July 16, 2009 |
Start Date | April 2008 |
Estimated Primary Completion Date | March 2009 |
Current Primary Outcome Measures | postprandial dynamics of intact proinsulin secretion after standardized test meals (AUC for two hours after dinner) [Time Frame: 12 +/- 2 weeks] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin |
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Official Title | Impact of Insulin (I.)Glargine Compared to NPH I. and to I. Detemir in Combination With Metformin on Prandial ß-cell Function and Overall Metabolic Control in Type 2 Diabetic Patients With Insufficient Metabolic Control During OAD Treatment |
Brief Summary | The aim of the study is to show that treatment with Glargine will lead to an improvement in beta cell function especially within times of maximal beta cell stress occurring after a meal. For this reason three different standardized test meals (breakfast, lunch, dinner) will be performed and the postprandial secretion of intact proinsulin levels will be measured. These measurements will be performed with patients treated in combination with metformin and insulin glargine versus metformin plus NPH insulin (within the core study) and if significant difference is observed, with a third treatment arm with metformin plus insulin detemir. Hypothesis is that the area under the curve (AUC) intact proinsulin levels within 2 hours after test meal dinner of metformin plus insulin glargin differs from AUC intact proinsulin levels of metformin plus NPH insulin. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Insulin Glargin Drug: NPH insulin Drug: Insulin detemir Drug: metformin metformin (2000 mg/day) |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 30 |
Estimated Completion Date | March 2009 |
Estimated Primary Completion Date | March 2009 |
Eligibility Criteria | Inclusion Criteria: - Type 2 Diabetes mellitus according to the ADA criteria - HbA1c between 6.5% and 8.5% - Individually optimized combination therapy with metformin in combination with sulfonylurea in a stable dosage within the last 3 months - Age between 40 and 75 years - Fasting intact proinsulin level > 7 pmol/Land < 20 pmol/Lat screening Exclusion Criteria: - Type 1 Diabetes mellitus - Pre-Treatment with insulin within the last 3 months prior to screening - Pre-Treatment with PPARy-agonists (glitazones) within the last 3 months prior to screening - Major micro- or macrovascular complications as judged by the investigator - BMI > 40 kg/m² - Hypokalemia (K < 3.5 mmol /L) - History of drug or alcohol abuse - Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures - History of severe or multiple allergies - Treatment with any other investigational drug within 3 months prior to screening - Progressive fatal disease - History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine > 1.3 mg/dL in women and > 1.7 mg/dL in men), neurological, psychiatric and/or haematological disease as judged by the investigator - Pregnancy or breast feeding - Sexually active women of childbearing potential not actively and consistently practicing birth control by using a medically accepted device or therapy |
Gender | Both |
Ages | 40 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Germany |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00941148 |
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Other Study ID Numbers | LANT_001 |
Has Data Monitoring Committee | Yes |
Information Provided By | ikfe-CRO GmbH |
Study Sponsor | ikfe-CRO GmbH |
Collaborators | IKFE Institute for Clinical Research and Development |
Investigators | Not Provided |
Verification Date | July 2009 |
Locations[ + expand ][ + ]
ikfe GmbH, Clinic Department | Mainz, RLP, Germany, 55116 |
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