Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia

NCT01269047 | Completed Phase 4 Results DMC

• 2 other identifiers: 2010 -436R01DK077166
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; Symlin; Byetta; CGMS iPro

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  6 months

Secondary Outcomes (1)

• Difference in HbA1C Between the Treatment and the Control Groups

  6 months

Study Arms (3)

Pramlintide + Insulin Group

EXPERIMENTAL

These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.

Drug: Pramlintide

Exenatide + Insulin Group

EXPERIMENTAL

This group will get Exenatide(Byetta) along with insulin before breakfast and supper.

Drug: Exenatide

Insulin monotherapy

ACTIVE COMPARATOR

This group will be on their regular insulin therapy.

Drug: Insulin

Interventions

Pramlintide DRUG

Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months

Also known as: Symlin

Pramlintide + Insulin Group

Exenatide DRUG

Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months

Also known as: Byetta, Type 1 diabetes

Exenatide + Insulin Group

Insulin DRUG

Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.

Also known as: Novolog, Humalog, Levemir, Lantus

Insulin monotherapy

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Albert Einstein College of Medicine West Campus Clinical Research Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

pramlintide; Exenatide; Insulin; Insulin Aspart; Insulin Lispro; Insulin Detemir; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Short-Acting; Insulin, Long-Acting

Results Point of Contact

• Title: Dr. Rubina Heptulla
• Organization: Children's Hospital at Montefiore

rheptull@montefiore.org

718-920-7004

Study Officials

• Rubina A Heptulla, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Pediatric Endocrinology & Diabetes

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: January 4, 2011
• Study Start: August 1, 2009
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 12, 2018
• Results First Posted: February 8, 2018

Record last verified: 2018-03

Locations

US (1)