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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
  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.


Condition Intervention Phase
Type 2 Diabetic Patients
Insufficient Metabolic Control
OAD Treatment
 Drug: Insulin Glargin
Drug: NPH insulin
Drug: Insulin detemir
Drug: metformin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ikfe-CRO GmbH:

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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin glargine
Insulin glargine, dose individually adapted to reach treatment goal (FBG < 100 mg/dL)
 Drug: Insulin Glargin Drug: metformin
metformin (2000 mg/day)
Active Comparator: NPH Insulin
NPH Insulin, dose individually adapted to reach treatment goal (FBG < 100 mg/dL)
 Drug: NPH insulin Drug: metformin
metformin (2000 mg/day)
Active Comparator: Insulin detemir
Insulin detemir, dose individually adapted to reach treatment goal (FBG < 100 mg/dL)
 Drug: Insulin detemir Drug: metformin
metformin (2000 mg/day)

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941148

Locations
Germany
ikfe GmbH, Clinic Department
Mainz, RLP, Germany, 55116
Sponsors and Collaborators
ikfe-CRO GmbH
IKFE Institute for Clinical Research and Development
  More Information

No publications provided by ikfe-CRO GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Thomas Forst, MD, ikfe GmbH
ClinicalTrials.gov Identifier: NCT00941148     History of Changes
Other Study ID Numbers: LANT_001, EudraCT Number: 2007-006109-26
Study First Received: July 16, 2009
Last Updated: July 16, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Glargine
Insulin
Insulin, NPH
Metformin
 Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013