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Characteristics of Glargine in Type 2 Diabetics
This study is ongoing, but not recruiting participants.
First Received: December 13, 2007   Last Updated: June 23, 2009   History of Changes
Sponsors and Collaborators: Vanderbilt University
Sanofi-Aventis
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00574912
  Purpose

The study is to determine the dose response relationship of insulin glargine in type 2 diabetes over a 24-hour period and measuring the differences in glucose production among the differing doses of glargine.

Hypothesis: Differing doses of insulin glargine over a 24-hour period in type 2 diabetes will show differing effects on endogenous glucose production, glucose disposal and carbohydrate and lipid flux.


Condition Intervention
Type 2 Diabetes
Drug: Insulin Glargine

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment
Official Title: A Comparison of PK/PD Dose Response Characteristics of Glargine in Type 2 Diabetics

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Endogenous Glucose Production [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: March 2007
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Placebo
Drug: Insulin Glargine
administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five
2: Experimental
0.5 units of Glargine/kg body weight
Drug: Insulin Glargine
administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five
3: Experimental
1 unit of glargine/kg body weight
Drug: Insulin Glargine
administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five
4: Experimental
1.5 units of glargine/kg body weight
Drug: Insulin Glargine
administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five
5: Experimental
2.0 units of glargine/kg body weight
Drug: Insulin Glargine
administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five

Detailed Description:

The incidence of type 2 DM is increasing worldwide at an alarming rate. Unfortunately, the number of individuals with glycemic control at or below the American Diabetes Association goal of 7% has dropped. In fact, the number of patients with their important cardiometabolic risk factors of glucose, lipids and blood pressure at goal is only 7%. One of the reasons for this lack of metabolic control in type 2 DM is the continued relative underutilization of insulin. Diabetes is an insulin deficient state and requires appropriate physiologic replacement of insulin. Physiologic replacement of insulin requires a basal component to restrain overnight endogenous glucose production, lipolysis and proteolysis. The other component involves prandial insulin to regulate post prandial glucose levels. Recently, insulin glargine was introduced as a once-a-day peakless basal insulin. This form of basal insulin reproduces the normal constitutive physiologic release of insulin from the pancreas. Insulin glargine represents a breakthrough in treatment as the previous available "basal insulins" either produced peaks of activity (which are disadvantageous as this results in hypoglycemia) or do not last 24 hrs which results in post absorbative hyperglycemia. Despite the undoubted advantages of insulin glargine, there remains a lack of information regarding some aspects of glargine action. The study objectives are: 1) to determine the pharmacokinetic and pharmacodynamic dose response relationship of insulin glargine in Type 2 DM; 2) partition the dose response relationship of insulin glargine on endogenous glucose production and glucose uptake in Type 2 DM; and 3) to determine if the pharmacokinetic and pharmacodynamics of insulin glargine are consistent over a wide range of doses.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12 adults (males or females) with type 2 diabetes for at least six (6) months. May be using oral agents (SUs, metformin, acarbose or glitinides) with or without insulin.
  • HgbA1c 7 -12%
  • Age 18-70 years
  • BMI 27-40 kg/m²

Exclusion Criteria:

  • Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study
  • Evidence of hepatic, renal or cardiac failure
  • Abnormal results following screening tests
  • Pregnant or lactating females or females of childbearing potential who are unwilling to abstain from sexual intercourse or use reliable, medically accepted methods of contraception
  • Currently using TZDs
  • History of alcoholism or drug abuse within 12 months of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574912

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Sanofi-Aventis
Investigators
Principal Investigator: Stephen N. Davis, MD, FRCP Vanderbilt University
  More Information

No publications provided

Responsible Party: Vanderbilt University ( Stephen N. Davis, MD )
Study ID Numbers: IRB#060887-Lantus Glargine, VUMC 32787
Study First Received: December 13, 2007
Last Updated: June 23, 2009
ClinicalTrials.gov Identifier: NCT00574912     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Type 2 diabetes
Insulin Glargine
Endogenous Glucose Production

Study placed in the following topic categories:
Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Glargine
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on September 11, 2009