Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin
NCT ID: NCT00941148
Last Updated: 2009-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2008-04-30
2009-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin glargine
Insulin glargine, dose individually adapted to reach treatment goal (FBG \< 100 mg/dL)
Insulin Glargin
metformin
metformin (2000 mg/day)
NPH Insulin
NPH Insulin, dose individually adapted to reach treatment goal (FBG \< 100 mg/dL)
NPH insulin
metformin
metformin (2000 mg/day)
Insulin detemir
Insulin detemir, dose individually adapted to reach treatment goal (FBG \< 100 mg/dL)
Insulin detemir
metformin
metformin (2000 mg/day)
Interventions
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Insulin Glargin
NPH insulin
Insulin detemir
metformin
metformin (2000 mg/day)
Eligibility Criteria
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Inclusion 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
* 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
40 Years
75 Years
ALL
No
Sponsors
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IKFE Institute for Clinical Research and Development
OTHER
ikfe-CRO GmbH
INDUSTRY
Responsible Party
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ikfe GmbH
Locations
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ikfe GmbH, Clinic Department
Mainz, RLP, Germany
Countries
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References
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Forst T, Larbig M, Hohberg C, Forst S, Diessel S, Borchert M, Roth W, Pfutzner A. Adding insulin glargine vs. NPH insulin to metformin results in a more efficient postprandial beta-cell protection in individuals with type 2 diabetes. Diabetes Obes Metab. 2010 May;12(5):437-41. doi: 10.1111/j.1463-1326.2010.01209.x.
Other Identifiers
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EudraCT Number: 2007-006109-26
Identifier Type: -
Identifier Source: secondary_id
LANT_001
Identifier Type: -
Identifier Source: org_study_id
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