Efficacy of Pramlintide on Prevention of Weight Gain Early Onset of Type 1 Diabetes

NCT00505882 | Withdrawn Phase 4 DMC

• 1 other identifier: 032007-054
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In this pilot study we are evaluating the efficacy of pramlintide on preventing weight gain among early onset type 1 diabetes. We are also evaluating the safety and the effects of treatment with pramlintide on early diagnosed type 1 diabetic subjects, especially among pediatric subjects.

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetes; Pramlintide; Weight gain; Intensive insulin therapy; Beta cell

Outcome Measures

Primary Outcomes (1)

• The change in weight (kg) will be compared between as well as within the placebo and the pramlintide treatment group from baseline to the end of the study.

  6 months

Secondary Outcomes (1)

• mixed meal tolerance test-the C-peptide area under the curve The HOMA R and McAuley's index HbA1c The event rate of severe hypoglycemia Waist circumference Cardio C-reactive protein level DQOL Safety parameter

  6 months

Study Arms (2)

Insulin

ACTIVE COMPARATOR

Drug: Glargine; Drug: Lispro; Drug: Aspart

Pramlintide

EXPERIMENTAL

Drug: Pramlintide; Drug: Glargine; Drug: Lispro; Drug: Aspart

Interventions

Pramlintide DRUG

Pramlintide will be started at 15 mcg (2.5 units) subcutaneously immediately prior to major meals and it will be increased by 15mcg every 3 days as tolerated (i.e. nausea, vomiting, upset stomach) to a maximum dose of 60 mcg (10 units) before meals. If significant nausea persists at 45 or 60 mcg level, the dose should be decreased to 30 mcg (5 units) before meals. If the 30 mcg dose is not tolerated, investigator will evaluate for possibility of withdrawing the pramlintide. The dose of preprandial short acting insulin (eg: Novolog/Humalog) will be reduced by 30 to 50% at the start of pramlintide 15 mcg (2.5 units) and then will be adjusted every time the dose of pramlintide is increased by 15 mcg (2.5 units) as needed based on blood glucose readings.

Also known as: Symlin

Pramlintide

Glargine DRUG

Insulin; Pramlintide

Lispro DRUG

Insulin; Pramlintide

Aspart DRUG

Insulin; Pramlintide

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• to 40 years old
• Type 1 diabetes
• Fasting C-peptide ≤ 1.0 ng/ml
• Early diagnosed type 1 diabetes. (\<6 months since diagnosis of type 1 diabetes.)
• HbA1c greater than 7.0 %
• Male, or If female, is nonlactating and has a negative pregnancy test (human chorionic gonadotropin, beta subunit \[βhCG\]) at Visit 1 (screening).

You may not qualify if:

• Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
• Hepatic disease
• Gastrointestinal disease
• Haematologic disorder
• Cardiovascular disorder
• Organ transplantation
• Hemochromatosis
• HIV, HBV, or HCV infection
• Abuses drugs or alcohol or has a history of abuse
• Eating disorder
• Has donated blood within 60 days
• Has had major surgery or a blood transfusion within 2 months
• Usage of medications that affect weight changes
• Use of medications that affect gastrointestinal motility
• Usage of medications that affect glucose/insulin metabolism

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Weight Gain

Interventions

pramlintide; Insulin Glargine; Insulin Lispro; Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Philip Raskin, M.D.

  UT Southwestern at Dallas

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 25, 2007
• Study Start: July 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 8, 2019

Record last verified: 2019-01

Locations

US (1)