Phase 4 · Exenatide

NCT01269047 trial results

Exenatide (Byetta) Vs Pramlintide (Symlin): Role in Post-prandial Hyperglycemia

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. (mmol/L), 6 months. Acute Pramlintide + Insulin Group: 9.03; Acute Exenatide + Insulin Group: 8.4; Chronic Pramlintide + Insulin Group: 8.0; Chronic Exenatide + Insulin Group: 10.2; Insulin Monotherapy: 10.8.

Participants
37
Status
completed
Completed
2016-12
Sponsor
Albert Einstein College of Medicine

As posted on ClinicalTrials.gov (NCT01269047), updated at source Apr 12, 2018. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01269047 measured first

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.mmol/L · 6 months · mean
Acute Pramlintide + Insulin Groupn=12Acute Exenatide + Insulin Groupn=11Chronic Pramlintide + Insulin Groupn=11Chronic Exenatide + Insulin Groupn=11Insulin Monotherapyn=10
9.03(1.6)8.4(1.3)8.0(2.0)10.2(1.9)10.8(3.8)
Side effects by arm

Side effects in NCT01269047

Percent of participants affected. The most common events the registry lists.

EventPramlintide + Insulin GroupExenatide + Insulin GroupInsulin Monotherapy
Any serious event0%0%0%
Diabetic Ketoacidosis (DKA)7.7%7.7%0%
Secondary outcomes

What else it measured

Difference in HbA1C Between the Treatment and the Control Groupspercentage of HbA1C values · 6 months · mean
Acute Pramlintide + Insulin Groupn=12Acute Exenatide + Insulin Groupn=11Chronic Pramlintide + Insulin Groupn=11Chronic Exenatide + Insulin Groupn=11Insulin Monotherapyn=10
0.30(0.8)0.60(0.1)0.23(0.6)0.40(1.0)-0.40(0.9)
The trial

How NCT01269047 was run

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.

  • Pramlintide + Insulin Group: These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.
  • Exenatide + Insulin Group: This group will get Exenatide(Byetta) along with insulin before breakfast and supper.
  • Insulin monotherapy: This group will be on their regular insulin therapy.
Who could join the trial

Inclusion Criteria: 1. Age of 12 to 21 years. 2. HbA1C less than 9% 3. Subjects must be on intensive insulin management 4. Tanner stage greater than or equal to 3 5. Having Type 1 Diabetes for at least one year 6. 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 7. Willing to give consent. Exclusion Criteria: 1. Type 2 diabetes. 2. Having any other chronic condition except hypothyroidism stable on medications. 3. On chronic medications that may affect glucose excursions. 4. Anemia as defined as Hb less than 9 gm/dl. 5. Abnormal amylase, lipase or creatinine (twice normal). 6. Abnormal Liver function tests(three times above normal) 7. Unsupportive family environment as determined by clinicians and/or social workers. 8. Pregnant or lactating mothers

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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