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

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Insulin Lispro.

The researchers are also evaluating the safety and the effects of treatment with pramlintide on early diagnosed type 1 diabetic subjects, especially among pediatric subjects.

It had two arms (groups): Insulin (active comparator) and Pramlintide (experimental).

The registry classes the interventions as drug.

More on the Plan

The autoimmune process along with a strong genetic-mediated destruction and dysfunction of pancreatic β-cells are the main pathogeneses of type 1 diabetes.

These processes cause absolute and relative insulin and amylin deficiencies.

For the last decades, insulin therapy has been the primary therapy for type 1 diabetes.

Amylin is a 37 amino acid peptide hormone co-secreted with insulin mostly by the pancreatic β cells in response to meals.

Who Took Part

It was open to people of any sex aged from 12 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 12 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.). Male, or If female, is nonlactating and has a negative pregnancy test (human chorionic gonadotropin, beta subunit \[βhCG\]) at Visit 1 (screening).

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: hepatic disease; gastrointestinal disease; haematologic disorder.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2007-07 with completion listed for 2008-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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 (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the Insulin Lispro compound page, all human trials.