Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin

This study has been completed.

Sponsor:

Collaborator:

IKFE Institute for Clinical Research and Development

Information provided by:

ikfe-CRO GmbH

ClinicalTrials.gov Identifier:

NCT00941148

First received: July 16, 2009

Last updated: NA

Last verified: July 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	July 16, 2009
Last Updated Date	July 16, 2009
Start Date ^ICMJE	April 2008
Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 16, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: July 16, 2009)	AUC for intact proinsulin levels for two hours after a standardized test meal (breakfast and lunch) [ Time Frame: 12 +/- 2 weeks ] [ Designated as safety issue: No ] increase of intact proinsulin after breakfast (BF), lunch (LU) and dinner (DI) [ Time Frame: 12 +/- 2 weeks ] [ Designated as safety issue: No ] Ratio of exogenous insulin vs. endogenous insulin (measurements of glargine, NPH Insulin, detemir and human insulin levels) [ Time Frame: 12 +/- 2 weeks ] [ Designated as safety issue: No ] Postprandial endothelial function measured as postischaemic response in LDF measurements (after BF, LU, DI) [ Time Frame: 12 +/- 2 weeks ] [ Designated as safety issue: No ] Postprandial change in and AUC for hs CRP (after BF, LU, DI) [ Time Frame: 12 +/- 2 weeks ] [ Designated as safety issue: No ] Postprandial change in and AUC for ADMA (after BF, LU, DI) [ Time Frame: 12 +/- 2 weeks ] [ Designated as safety issue: No ] Postprandial increase in and AUC for glucose levels (after BF, LU, DI) [ Time Frame: 12 +/- 2 weeks ] [ Designated as safety issue: No ] Changes in FBG [ Time Frame: 12 +/- 2 weeks ] [ Designated as safety issue: No ] Changes in 8-point BG profiles [ Time Frame: 12 +/- 2 weeks ] [ Designated as safety issue: No ] Percentage of patients reaching the treatment goal [ Time Frame: 12 +/- 2 weeks ] [ Designated as safety issue: No ] Insulin dosage per kg body weight to reach treatment goal [ Time Frame: 12 +/- 2 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Type 2 Diabetic Patients Insufficient Metabolic Control OAD Treatment
Intervention ^ICMJE	Drug: Insulin Glargin Drug: NPH insulin Drug: Insulin detemir Drug: metformin metformin (2000 mg/day)
Study Arm (s)	Active Comparator: Insulin glargine Insulin glargine, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) Interventions: Drug: Insulin Glargin Drug: metformin Active Comparator: NPH Insulin NPH Insulin, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) Interventions: Drug: NPH insulin Drug: metformin Active Comparator: Insulin detemir Insulin detemir, dose individually adapted to reach treatment goal (FBG < 100 mg/dL) Interventions: Drug: Insulin detemir Drug: metformin
Publications *	Forst T, Larbig M, Hohberg C, Forst S, Diessel S, Borchert M, Roth W, Pfützner 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	March 2009
Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00941148
Other Study ID Numbers ^ICMJE	LANT_001, EudraCT Number: 2007-006109-26
Has Data Monitoring Committee	Yes
Responsible Party	Prof. Thomas Forst, MD, ikfe GmbH
Study Sponsor ^ICMJE	ikfe-CRO GmbH
Collaborators ^ICMJE	IKFE Institute for Clinical Research and Development
Investigators ^ICMJE	Not Provided
Information Provided By	ikfe-CRO GmbH
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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