A Phase 1 interventional study of Placebo and Insulin Glargine 0.5 u/kg body wt SC in Type 2 Diabetes, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-04-17.
Sponsored by Vanderbilt University Medical Center · Phase 1, Interventional, and Treatment
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
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Exclusion Criteria:
Placebo: administer single dose of Placebo subcutaneously (SC) with blood glucose monitoring over 24 hours. Then Insulin Glargine SQ 8 weeks later, in increasing doses (0.5, 1.0, 1.5, 2.0 u/kg body wt.) with blood glucose monitoring monitoring over a 24 hour period. Each dose is separated by 8 weeks (5 separate study visits)
Drug: Placebo · Drug: Insulin Glargine 0.5 u/kg body wt SC · Drug: Insulin Glargine 1.0 u/kg body wt SC · Drug: Insulin Glargine 1.5 u/kg body wt SC · Drug: Insulin Glargine 2.0 u/kg body wt SC
single dose of Placebo injected s/c at 8am and monitor blood glucose over 24 hours
Also known as: Lantus
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)
Also known as: Lantus
Also known as: Lantus
Also known as: Lantus
Also known as: Lantus
Maximum Glucose Infusion Rate
measuring the changes in glucose infusion rate during the 24 hour experimental period.
Time frame: 24 hours
12 individuals will be their own controls completing 5 separate 24 hour protocol studies. If a participant does not complete all protocols, another person will be recruited to complete the protocols until there are 12 completed studies in each arm/group.
| Milestone | 1 All Interventions |
|---|---|
| Started | 20 |
| Completed placebo | 12 |
| Completed 0.5 | 12 |
| Completed 1.0 | 12 |
| Completed 1.5 | 12 |
| Completed 2.0 | 12 |
| Completed | 12 |
| Not completed | 8 |
| Withdrew: Could not place iv lines. | 3 |
| Withdrew: Scheduling conflicts | 3 |
| Withdrew: Physician decision | 2 |
measuring the changes in glucose infusion rate during the 24 hour experimental period.
| umol/kg/min | Placebo | 0.5 Units of Glargine/kg | 1.0 Units of Glargine/kg | 1.5 Units of Glargine/kg | 2.0 Units of Glargine/kg |
|---|---|---|---|---|---|
| Maximum Glucose Infusion Rate | 0.3 ± 0.3 | 2.6 ± 0.9 | 5.5 ± 1.5 | 6.8 ± 2.0 | 9.5 ± 2.1 |
Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/12 (0%) | 0/12 (0%) |
| 0.5 Units of Glargine/kg Body Weight | — | 0/12 (0%) | 0/12 (0%) |
| 1 Unit of Glargine/kg Body Weight | — | 0/12 (0%) | 0/12 (0%) |
| 1.5 Units of Glargine/kg Body Weight | — | 0/12 (0%) | 0/12 (0%) |
| 2.0 Units of Glargine/kg Body Weight | — | 0/12 (0%) | 0/12 (0%) |
One participant may have received more than one intervention.
| Age, Categorical(Participants) | 1--All Interventions |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | 1--All Interventions |
|---|---|
| Female | 10 |
| Male | 10 |
| Region of Enrollment(participants) | 1--All Interventions |
|---|---|
| United States | 20 |
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center