We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00941148
First Posted: July 17, 2009
Last Update Posted: July 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
IKFE Institute for Clinical Research and Development
Information provided by:
ikfe-CRO GmbH
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • AUC for intact proinsulin levels for two hours after a standardized test meal (breakfast and lunch) [ Time Frame: 12 +/- 2 weeks ]
  • increase of intact proinsulin after breakfast (BF), lunch (LU) and dinner (DI) [ Time Frame: 12 +/- 2 weeks ]
  • Ratio of exogenous insulin vs. endogenous insulin (measurements of glargine, NPH Insulin, detemir and human insulin levels) [ Time Frame: 12 +/- 2 weeks ]
  • Postprandial endothelial function measured as postischaemic response in LDF measurements (after BF, LU, DI) [ Time Frame: 12 +/- 2 weeks ]
  • Postprandial change in and AUC for hs CRP (after BF, LU, DI) [ Time Frame: 12 +/- 2 weeks ]
  • Postprandial change in and AUC for ADMA (after BF, LU, DI) [ Time Frame: 12 +/- 2 weeks ]
  • Postprandial increase in and AUC for glucose levels (after BF, LU, DI) [ Time Frame: 12 +/- 2 weeks ]
  • Changes in FBG [ Time Frame: 12 +/- 2 weeks ]
  • Changes in 8-point BG profiles [ Time Frame: 12 +/- 2 weeks ]
  • Percentage of patients reaching the treatment goal [ Time Frame: 12 +/- 2 weeks ]
  • Insulin dosage per kg body weight to reach treatment goal [ Time Frame: 12 +/- 2 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 16, 2009
First Posted: July 17, 2009
Last Update Posted: July 17, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Metformin
Insulin Glargine
Insulin Detemir
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs