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

Novartis

Status and phase: Completed; Phase 2

Conditions: Impaired Glucose Tolerance; Type 2 Diabetes Mellitus

Treatments: Drug: Canakinumab 150 mg; Drug: Placebo to Canakinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01068860

CACZ885I2207

Details and patient eligibility

About

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.

Enrollment: 246 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient must fulfill all criteria in one of the following groups:

   • Impaired Glucose Tolerance (IGT) as diagnosed per protocol and not on an anti-diabetic medicine during the study
   • Diagnosis of Type 2 diabetes in stable treatment with metformin
   • Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day) in combination with a sulfonylurea
   • Diagnosis of Type 2 diabetes in stable treatment with metformin (at least 1000 mg/day), sulfonylurea and thiazolidinedione combination therapy
   • Diagnosis of Type 2 diabetes in stable treatment with at least two insulin injections a day with or without metformin

2. HbA1c between 6.5% and 8%, inclusive, at Screening; this criterion does not apply to the IGT group

3. Age from 18-74 years, inclusive, and of either sex

Exclusion criteria

1. Type 1 diabetes or diabetes that is a result of pancreatic injury or other secondary forms of diabetes
2. History or current findings of active pulmonary disease (e.g. tuberculosis, fungal diseases) as defined in the protocol:
3. Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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246 participants in 10 patient groups, including a placebo group

Canakinumab 150 mg + Metformin

Experimental group

Description:

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

Treatment:

Drug: Canakinumab 150 mg

Placebo + Metformin

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to Canakinumab

Canakinumab 150 mg + Metforimin + Sulfonylurea

Experimental group

Description:

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.

Treatment:

Drug: Canakinumab 150 mg

Placebo + Metforimin + Sulfonylurea

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo to Canakinumab

Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione

Experimental group

Description:

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.

Treatment:

Drug: Canakinumab 150 mg

Placebo + Met + Sulfonyl + Thiazolidinedione

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo to Canakinumab

Canakinumab 150 mg + Insulin

Experimental group

Description:

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

Treatment:

Drug: Canakinumab 150 mg

Placebo + Insulin

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo to Canakinumab

Canakinumab 150 mg in patients with IGT

Experimental group

Description:

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.

Treatment:

Drug: Canakinumab 150 mg

Placebo in patients with IGT

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo to Canakinumab