Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Efalizumab (Raptiva) Combined With Sirolimus in Type 1 Diabetic Islet Allograft Recipients

Conditions

Type 1 Diabetes Mellitus, Hypoglycemia

Being tested

Allogeneic islets of Langerhans transplant, Raptiva, Sirolimus, anti-thymocyte globulin

Keywords

Islet transplant, Diabetes Mellitus, Hypoglycemia

Medical subject headings

Diabetes Mellitus, Type 1, Hypoglycemia, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Allogeneic islets of Langerhans transplantBiological

  Also called Islets

  Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.

• RaptivaDrug

  Also called Efalizumab

  Treatment Day -1 pretransplant to Treatment Day 90 after tx.: 1.0 mg/kg/wk SQ; Treatment Day 91 to Treatment Day 365: 0.5 mg/kg/wk SQ;

• SirolimusDrug

  Also called Rapamune

  Initial dose 0.1 mg/kg PO on day -2, followed by 0.05 mg/kg daily, whole blood 24-hour trough adjusted to target 3-15 ng/ml as tolerated

• anti-thymocyte globulinDrug

  Also called ATG, Thymoglobulin

  2.0 mg/kg on days -2, and -1 IV

What is being measured

The primary outcome is the main question the study is designed to answer.

1. The Proportion of Insulin-independent Subjects With Full Islet Graft Function

   Islet transplant recipients will be considered insulin-independent with full islet graft function if they are able to titrate off insulin therapy for at least 1 week and all of the following criteria are met:

   • HbA1c < 7.0% or a ≥2.5% decrease from baseline;
   • fasting capillary glucose level should not exceed 140 mg/dL (7.8 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 7 times in a seven day period);
   • 2-hour post-prandial capillary glucose should not exceed 180 mg/dl (10.0 mmol/L) more than three times in the past week (based on measuring capillary glucose levels a minimum of 21 times in a seven day period);
   • fasting serum glucose level ≤126 mg/dL (7.0 mmol/L); if the fasting serum glucose level is >126 mg/dL (7.0 mmol/L), it must be confirmed in an additional one out of two measurements;
   • evidence of endogenous insulin production defined as fasting or stimulated C-peptide levels ≥0.5 ng/mL (0.16 nmol/L).

   Measured: 1 year following the first islet transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 May 2008 (estimated)
2. Study startNov 2007
3. Primary completionDec 2010
4. Study completionAug 2012

Why it stopped: Raptiva was withdrawn from the market

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
• More trials run by University of MinnesotaThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.