Characteristics of Glargine in Type 2 Diabetics
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): Placebo; Insulin Glargine 0.5 u/kg body wt SC; Insulin Glargine 1.0 u/kg body wt SC; Insulin Glargine 1.5 u/kg body wt SC; Insulin Glargine 2.0 u/kg body wt SC
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose of Placebo injected s/c at 8am and monitor blood glucose over 24 hours; 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)
Other intervention name(s): Lantus; Lantus; Lantus; Lantus; Lantus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Insulin Glargine; Endogenous Glucose Production