To Compare the Effect of a Subcutaneous Canakinumab Administration to Placebo in Patients With Impaired Glucose Tolerance or Patients With Type 2 Diabetes With Differing Baseline Diabetes Therapies

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis
Study ID
NCT01068860
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This was a 10-week, placebo-controlled, randomized study to investigate the effect of injectable IL-1B antagonist, Canakinumab , in participants with impaired glucose tolerance or Type 2 Diabetes Mellitus (T2DM) already treated on different background diabetes therapies.

Key Dates

Start date
Feb 28, 2010
Status verified
Aug 2011
Primary completion
Aug 31, 2010
Completion
Aug 31, 2010

Study Design

Enrollment
246 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canakinumab 150 mg + Metformin
    Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
  • Placebo Comparator: Placebo + Metformin
    Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
  • Experimental: Canakinumab 150 mg + Metforimin + Sulfonylurea
    Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
  • Placebo Comparator: Placebo + Metforimin + Sulfonylurea
    Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
  • Experimental: Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione
    Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
  • Placebo Comparator: Placebo + Met + Sulfonyl + Thiazolidinedione
    Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
  • Experimental: Canakinumab 150 mg + Insulin
    Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
  • Placebo Comparator: Placebo + Insulin
    Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
  • Experimental: Canakinumab 150 mg in patients with IGT
    Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
  • Placebo Comparator: Placebo in patients with IGT
    Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.

Primary Outcome Measure

Mean Change in Meal Stimulated Insulin Secretion Rate (ISR) Relative to Glucose 0-2 Hours, From Baseline to 4 Weeks. [ Time Frame: Baseline, 4 weeks ]

Locations (11)

FacilityCityStateZIPSite coordinators
National Research InstituteLos AngelesCalifornia--
Crest Clinical TrialsSanta AnaCalifornia--
Encompass Clinical ResearchSpring ValleyCalifornia--
Commonwealth Biomedical Research LLCMadisonvilleKentucky--
University of Nebraska Medical CenterOmahaNebraska--
VA Medical CenterOmahaNebraska--
Lillestol Research LLCFargoNorth Dakota--
Preferred Primary Care PhysiciansPittsburghPennsylvania--
Dallas Diabetes and Endocrine CenterDallasTexas--
Texas Center for Drug Development P.A.HoustonTexas--
Utah Clinical TrialsSalt Lake CityUtah--

Find similar trials in Los Angeles, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
National Research Institute· Los Angeles, CACrest Clinical Trials· Santa Ana, CAEncompass Clinical Research· Spring Valley, CACommonwealth Biomedical Research LLC· Madisonville, KYUniversity of Nebraska Medical Center· Omaha, NEVA Medical Center· Omaha, NE

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