Trial · Interventional

CompletedPhase 4Results postedRegistry data

Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia

NCTNCT01269047Other id2010 -436Other idR01DK077166

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 37 participants (actual)
Sponsor: Albert Einstein College of Medicine · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Aug 2009
Primary completion: Aug 2016
Completion: Dec 2016
First posted: 4 Jan 2011 (estimated)
Last update posted: 12 Apr 2018
Conditions: Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2010201220142016

Ph 4
Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia
NCT01269047
Aug 2009 to Dec 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

PramlintideDrug
ExenatideDrug
InsulinDrug

Arms3

Experimental
Pramlintide + Insulin Group
These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.
Experimental
Exenatide + Insulin Group
This group will get Exenatide(Byetta) along with insulin before breakfast and supper.
Active comparator
Insulin monotherapy
This group will be on their regular insulin therapy.

Primary outcomes1

Outcomes the sponsor listed as 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.
Time frame · 6 months
Registry description
We measured post-prandial blood sugars in both pramlintide and exenatide treated groups in acute and chronic setting, when compared to insulin monotherapy in subjects with Type 1 Diabetes Mellitus

Secondary outcomes(1)

Difference in HbA1C Between the Treatment and the Control Groups
Time frame · 6 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 6 months

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.

Group	Value (mmol/L)	Spread
Acute Pramlintide + Insulin Group	9.03	1.6
Acute Exenatide + Insulin Group	8.4	1.3
Chronic Pramlintide + Insulin Group	8.0	2.0
Chronic Exenatide + Insulin Group	10.2	1.9
Insulin Monotherapy	10.8	3.8

Secondary and other outcome results(1)

Secondary outcomeMean· 6 months

Difference in HbA1C Between the Treatment and the Control Groups

Group	Value (percentage of HbA1C values)	Spread
Acute Pramlintide + Insulin Group	0.30	0.8
Acute Exenatide + Insulin Group	0.60	0.1
Chronic Pramlintide + Insulin Group	0.23	0.6
Chronic Exenatide + Insulin Group	0.40	1.0
Insulin Monotherapy	-0.40	0.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Pramlintide + Insulin GroupThese kids will get Pramlintide (Symlin) along with insulin before breakfast and supper. Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months	0 / 13	0 / 13	1 / 13
Exenatide + Insulin GroupThis group will get Exenatide(Byetta) along with insulin before breakfast and supper. Exenatide: Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months	0 / 13	0 / 13	1 / 13
Insulin MonotherapyThis group will be on their regular insulin therapy. Insulin: Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.	0 / 11	0 / 11	0 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 12 Years up to 21 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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