Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia

NCT02685852 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 1503M65841
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the effectiveness of exenatide in adults experiencing episodes of hyperinsulinemic hypoglycemia following Roux-en-Y bariatric surgery.

Conditions

Hyperinsulinemic Hypoglycemia

Outcome Measures

Primary Outcomes (2)

• Glucose area under the curve (AUC) following treatment for each 4-hour test period

  Each time point (15, 30, 45, 60, 90, 120, 180 and 240 minutes) will be used to calculate AUC using the trapezoidal method.

  During the 4-hour test period

• Presence of hypoglycemia

  If at each time-point (15, 30, 45, 60, 90, 120, 180 and 240 minutes) plasma glucose is \<60 mg/dL, participants will be defined as hypoglycemic

  15, 30, 45, 60, 90, 120, 180 and 240 minutes

Secondary Outcomes (3)

• Minimum post-prandial blood sugar level (mg/dL)

  post meal test

• Change in post-prandial blood glucose from 0min to 120min

  0min to 120min

• Change in post-prandial Insulin levels (mcg/mL)

  0min to 120min

Study Arms (3)

Arm 1: Exenatide (5mcg) + Acarbose Placebo

ACTIVE COMPARATOR

Exenatide (5 mcg) 30 minutes before the high-carb meal is delivered and acarbose placebo immediately prior to the high-carb meal

Drug: Exenatide; Drug: Acarbose Placebo

Arm 2: Exenatide (5mcg) + Acarbose (25mg)

ACTIVE COMPARATOR

Exenatide (5 mcg) 30 minutes before the high-carb meal is delivered and acarbose (25 mg) immediately prior to the high-carb meal

Drug: Exenatide; Drug: Acarbose

Arm 3: Exenatide Placebo + Acarbose (25mg)

PLACEBO COMPARATOR

Exenatide placebo 30 minutes before the high-carb meal is delivered and acarbose (25 mg) immediately prior to the high-carb meal

Drug: Acarbose; Drug: Exenatide Placebo

Interventions

Exenatide DRUG

Exenatide at a dose of 5 mcg

Also known as: Byetta

Arm 1: Exenatide (5mcg) + Acarbose Placebo; Arm 2: Exenatide (5mcg) + Acarbose (25mg)

Acarbose DRUG

Acarbose at a dose of 25 mg

Arm 2: Exenatide (5mcg) + Acarbose (25mg); Arm 3: Exenatide Placebo + Acarbose (25mg)

Exenatide Placebo DRUG

Placebo for Exenatide

Arm 3: Exenatide Placebo + Acarbose (25mg)

Acarbose Placebo DRUG

Placebo for Acarbose

Arm 1: Exenatide (5mcg) + Acarbose Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• must have undergone RYGB and subsequently developed post-prandial hypoglycemia (defined as at least 3 episodes over a six-month period with documented capillary blood sugars \[\<60 mg/dL with hypoglycemic symptoms). Subjects may also have had a formal mixed meal tolerance test with post meal blood sugar \<60 mg/dL.
• Subjects who otherwise meet the study criteria above with hypoglycemia symptoms but who do not have documented hypoglycemia by plasma measurement may undergo a screening visit to document the requisite levels for consideration into the study.

You may not qualify if:

• Chronic or acute diseases of the liver.
• Chronic or acute diseases of the pancreas (including type 1 diabetes or pancreatitis or a history of pancreatitis). Subjects may have a diagnosis of type 2 diabetes but must no longer require diabetes medication.
• Chronic or acute diseases of the kidneys.
• Known malignancies and must not have a family history of medullary thyroid cancer.
• History of pre-RYGB hypoglycemia symptoms or low documented plasma glucose preoperatively.
• Pregnant or plans to become pregnant throughout study duration
• Breastfeeding

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Congenital Hyperinsulinism

Interventions

Exenatide; Acarbose

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypoglycemia

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Shalamar D Sibley, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 19, 2016
• Study Start: February 1, 2016
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: May 6, 2021

Record last verified: 2021-04

Locations

US (1)