A Phase 4 interventional study of Insulin and Pramlintide + Insulin in Type 1 Diabetes Mellitus, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2018-07-10.
Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment
The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial glucose excursions.
The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes.
Following approval by the Institutional Review Board at Baylor College of Medicine 8 adolescents (6 males, 2 females) with type 1 diabetes were recruited to the open-labeled, non-randomized, crossover study. Two male subjects were African American; the remaining subjects were all Caucasian. Six subjects were on insulin pump therapy, and the two on insulin glargine, self-administered at -90minutes. Subjects had their last meal before 12 midnight, and stayed at our research center from 7AM until completion of the study at 2PM. Study A was done before study B.
Basal insulin doses of the subjects were kept constant through studies A and B. No subject was prescribed pramlintide any time in the past prior to participation in this study.
Study A:Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, following which they received 12oz (591ml) of Boost High Protein drink (360 calories, 50gms carbohydrate, 12 gms fat) at 9AM (0 minutes). The Boost was consumed in 5 - 7 minutes. Blood samples were collected for the analysis of blood glucose (BG) levels at -60, -30, -10, and 0 minutes, and every 10 minutes thereafter for the first hour, every 20 minutes for the second hour, and every 30 minutes until the study ended. Blood samples were also collected throughout the study at multiple time points for the analysis of insulin and glucagon levels. Subjects were provided with lunch at 2PM, and discharged.
Study B:The study protocol was identical to study A except 30mcg of pramlintide was administered subcutaneously immediately prior to drinking the Boost at 9AM, and no insulin was given before the meal but was given 15 minutes after the meal (9:15AM) and the dose was reduced by 20%. Study B was conducted within 3 to 4 weeks of study A.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 8 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal
Drug: Insulin
30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
Drug: Pramlintide + Insulin
Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.
Also known as: aspart or lispro
30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
Also known as: Pramlintide Acetate
Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone
Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone
Time frame: 0 to 240 minutes post-dose
Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.
Glucagon concentration in terms of mean AUC (0 to 120 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone
Time frame: 0 to 120 minutes post-dose
Eight study subjects were screened and all subjects completed both study visits.
| Milestone | Insulin Therapy / Pramlintide + Insulin Therapy |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone
| mmol*L/min | Rapid Acting Insulin Therapy - Before Meal | Pre-meal Pramlintide and Post-meal Insulin Therapy |
|---|---|---|
| Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone | 205 ± 116 | 993 ± 141 |
Glucagon concentration in terms of mean AUC (0 to 120 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone
| ng*L/min | Rapid Acting Insulin Therapy - Before Meal | Pre-meal Pramlintide and Post-meal Insulin Therapy |
|---|---|---|
| Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone. | 6060 ± 459 | 7575 ± 479 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin Therapy | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Pramlintide + Insulin Therapy | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | Insulin Therpy / Pramlintide + Insulin Therapy |
|---|---|
| <=18 years | 8 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Insulin Therpy / Pramlintide + Insulin Therapy |
|---|---|
| Mean | 16.2 ± 1 |
| Sex: Female, Male(Participants) | Insulin Therpy / Pramlintide + Insulin Therapy |
|---|---|
| Female | 2 |
| Male | 6 |
| Region of Enrollment(Participants) | Insulin Therpy / Pramlintide + Insulin Therapy |
|---|---|
| United States | 8 |
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