Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Vanderbilt University Sanofi-Aventis |
---|---|
Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00574912 |
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 |
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
|
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Stephen N. Davis, MD, FRCP | Vanderbilt University |
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 |
Type 2 diabetes Insulin Glargine Endogenous Glucose Production |
Hypoglycemic Agents Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Diabetes Mellitus, Type 2 Glargine |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |