Phase 4
N=37
Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01269047 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Post-prandial Blood Glucose Concentration in Both Pramlintide and Exenatide Treated Groups in Acute and Chronic Setting, Compared to Insulin Monotherapy in Type 1 Diabetes Mellitus. — 9.03; 8.4; 8.0; 10.2 mmol/L — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pramlintide (Drug); Exenatide (Drug); Insulin (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-prandial Blood Glucose Concentration in Both Pramlintide and Exenatide Treated Groups in Acute and Chronic Setting, Compared to Insulin Monotherapy in Type 1 Diabetes Mellitus. |
9.03; 8.4; 8.0; 10.2; 10.8 | 0.04 sig |
| SECONDARY Difference in HbA1C Between the Treatment and the Control Groups |
0.30; 0.60; 0.23; 0.40; -0.40 | 0.2 |
Summary
The main purpose of the study is to determine the effects of 16 weeks of adjunctive pramlintide or exenatide use on glycemic control in Type 1 Diabetes.
Eligibility Criteria
Inclusion Criteria
- Age of 12 to 21 years.
- HbA1C less than 9%
- Subjects must be on intensive insulin management
- Tanner stage greater than or equal to 3
- Having Type 1 Diabetes for at least one year
- Type 1Diabetes defined by ADA criteria and having at least one of the following antibodies a. Anti-GAD (glutamic acid decarboxylase) b. Anti-islet cell 512 (ICA512) c. Anti-insulin
- Willing to give consent.
Exclusion Criteria
- Type 2 diabetes.
- Having any other chronic condition except hypothyroidism stable on medications.
- On chronic medications that may affect glucose excursions.
- Anemia as defined as Hb less than 9 gm/dl.
- Abnormal amylase, lipase or creatinine (twice normal).
- Abnormal Liver function tests(three times above normal)
- Unsupportive family environment as determined by clinicians and/or social workers.
- Pregnant or lactating mothers
Data sourced from ClinicalTrials.gov (NCT01269047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.