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Completed

NCT Number: NCT01103284

Efficacy and Safety Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Adults

This study will look at the treatment effect of DiaPep277 on preservation of beta-cell function, as defined by meal-stimulated secretion of insulin. DiaPep277 is a peptide that changes the way the immune system behaves, stopping its attack on the beta-cells.

Adults (>20 years) with newly diagnosed (<6 months) type 1 diabetes will be treated with 10 injections of DiaPep277 or Placebo over a 2-year treatment and follow-up period.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitatsklinik fur Innere Medzin I, Landeskrankenhaus, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of type 1 diabetes within last 6 months
  • Age 20-45 years
  • fasting basal C-peptide equal or greater than 0.22 nmol/L, lower than 0.8 nmol/L
  • BMI between 17 and 30 at screening

Exclusion criteria

  • Significant disease or condition other than type 1 diabetes
  • Diabetes-related complications
  • Ongoing treatment with immunosuppressive or immunomodulating agents including chronic corticosteroids

Treatment and study plan

DiaPep277

Drug

1.0 mg dose in 0.5 mL of solution

Placebo

Drug

40 mg mannitol in 0.5 mL of solution.

Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months

Primary outcomes

  1. Change From Baseline in Glucagon-Stimulated C-Peptide AUC at 24 Months

    Time frame: Baseline and 24 months

    Change in Beta-cell function, measured as stimulated C-peptide secretion 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at baseline and 24 months, during a glucagon stimulation test (GST). The change in AUC was calculated per patient by subtracting the baseline AUC from the 24 month AUC.

Secondary outcomes

  1. Percentage of Subjects That Achieve Good Glycemic Control: HbA1c<7%

    Time frame: 24 and 25 months

    The percentage of subjects achieving good glycemic control, i.e. an HbA1c <7% at study end (Month 25). If HbA1c was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with an HbA1c ≤ 7% at study end.

  2. Frequency of Hypoglycemic Events

    Time frame: Baseline to 25 Months

    Total number of days with at least one hypoglycemic event recorded

  3. Mean Number of Days With at Least One Hypoglycemic Event

    Time frame: Baseline to 25 months

Other outcomes

  1. Percentage of Subjects Requiring a Daily Insulin Dose ≤ 0.5 IU/kg at End of Study

    Time frame: 24 and 25 months

    Percentage of subjects requiring a daily insulin dose ≤ 0.5 IU/kg at end of study (25 Months). If insulin dose was missing at Month 25, but the Month 24 value was available, then the Month 24 value was used to calculate the percentage of subjects with a daily insulin dose ≤ 0.5 IU/kg at study end.

Sponsors and collaborators

Lead sponsor

Andromeda Biotech Ltd.

Industry

Registry information

Official study title

A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Clinical Efficacy and Safety of DiaPep277 in Newly Diagnosed Type 1 Diabetes Subjects

Acronym: DIA-AID2

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 14, 2010
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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