Characteristics of Glargine in Type 2 Diabetics

Type 2 Diabetes Clinical Trial

Official title:

A Comparison of PK/PD Dose Response Characteristics of Glargine in Type 2 Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574912
• Other study ID #: IRB#060887-Lantus Glargine
• Secondary ID: VUMC 32787
• Status: Completed
• Phase: N/A
• First received: December 13, 2007
• Last updated: July 2, 2015
• Start date: March 2007
• Est. completion date: January 2010

Study information

• Verified date: July 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Placebo or Insulin Glargine
administering single dose of Placebo injected s/c at 8am and monitoring blood glucose over 24 hours, then 8 weeks later, a differing dose (0.5, 1.0, 1.5, 2.0 u/kg body wt.) of Insulin Glargine and monitoring over a 24 hour period each separated by 8 weeks (5 separate study visits)

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Infusion Rate	measuring the changes in glucose infusion rate during the 24 hour experimental period.	24 hours	No