NCT00605475

Brief Summary

The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose tolerance test (OGTT).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_2 type-2-diabetes-mellitus

Geographic Reach
3 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 13, 2012

Completed
Last Updated

February 13, 2012

Status Verified

January 1, 2012

Enrollment Period

2.8 years

First QC Date

January 18, 2008

Results QC Date

September 1, 2011

Last Update Submit

January 10, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusCanakinumabACZ885IL-1B antagonistmetforminglycemic controlinsulin sensitivity

Outcome Measures

Primary Outcomes (2)

  • Mean Change From Baseline in Plasma HbA1c (Glycosylated Hemoglobin / Hemoglobin A1c)

    Blood was drawn after an overnight fast to measure plasma HbA1c levels. End of Study is defined as the last Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.

    Baseline, Day 28, Day 84, Day 126, End of Study (168 [+/- 5] days after dosing)

  • Mean Change From Baseline in Plasma Glucose Area Under the Curve (AUC) 0 - 4 Hours Following Oral Glucose Tolerance Test (OGTT )

    Mean Change in Glucose level stimulated by OGTT. Blood samples were taken at sample times: -20, -10, -1 and 10, 20, 30, 60, 90, 120, 180, and 240 minutes. Glucose levels over 4 hrs were shown as Area Under the Curve, (AUC). Analysis of covariance with treatment as a fixed effect and baseline as the covariate was performed.

    Baseline, Day 28, Day 84

Secondary Outcomes (14)

  • Mean Change From Baseline in Plasma C-peptide AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test (OGTT)

    Baseline, Day 28, Day 84

  • Mean Change From Baseline in Plasma Insulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )

    Baseline, Day 28, Day 84

  • Mean Change From Baseline in Plasma Proinsulin AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test ( OGTT )

    Baseline, Day 28, Day 84

  • Mean Change From Baseline in Plasma Glucagon AUC ( Area Under the Curve) 0-4 Hours, Following Oral Glucose Tolerance Test

    Baseline, Day 28, Day 84

  • Mean Change From Baseline in Peak Plasma Insulin/Proinsulin Level, Following Oral Glucose Tolerance Test (OGTT)

    Baseline, Day 28, Day 84

  • +9 more secondary outcomes

Study Arms (2)

Canakinumab

EXPERIMENTAL

Eligible participants were assigned to receive canakinumab in one of four cohorts; 1) Single IV infusion of canakinumab 0.3 mg/kg; 2) Singe IV infusion of canakinumab 10 mg/kg; 3) single IV infusion of canakinumab 0.1 mg/kg or 0.3 mg/kg, or 1.5 mg/kg; 4) Single IV injection of canakinumab 0.03 mg/kg. All participants were required to take a concomitant stable daily dose of metformin during the study.

Drug: CanakinumabDrug: Metformin

Placebo

PLACEBO COMPARATOR

Eligible participants were assigned to receive placebo to canakinumab in one of four cohorts; 1) Single IV infusion of placebo to canakinumab 0.3 mg/kg; 2) Singe IV infusion of placebo to canakinumab 10 mg/kg; 3) single IV infusion of placebo to canakinumab 0.1 mg/kg or 0.3 mg/kg, or 1.5 mg/kg; 4) Single IV injection of placebo to canakinumab 0.03 mg/kg. All participants were required to take a concomitant stable daily dose of metformin during the study.

Drug: PlaceboDrug: Metformin

Interventions

CanakinumabDRUG

Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.

Also known as: ACZ885
Canakinumab
PlaceboDRUG

Placebo to Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.

Placebo
MetforminDRUG

Participants continued on their stable daily dose of metformin throughout the study

Also known as: Glucophage, Glumetza
CanakinumabPlacebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients aged 18 to 70 years, with type 2 diabetes mellitus (non-insulin dependent diabetes) for at least 6 months prior to study start
  • HbA1c between 7.0 and 9.5%
  • On stable dose metformin monotherapy
  • Stable body weight

You may not qualify if:

  • Poorly controlled type 2 diabetes (very low or very high blood sugar levels, or other indicators of poor control)
  • Acute infections prior to dosing
  • Patients with type 1 diabetes (insulin-dependent diabetes)
  • Taking diabetes medication (other than metformin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Arkansas Research Medical Testing

Little Rock, Arkansas, 72202, United States

Location

Allied Research International - Cetero Research Miami

Miami, Florida, 33169, United States

Location

Elite Research Institute Miami

Miami, Florida, 33169, United States

Location

International Research Center Towson

MD, Maryland, 21286, United States

Location

Covance Clinical Research Unit Inc

Portland, Oregon, 97239, United States

Location

Charles River Clinical Services

Northwest Tacoma, Washington, 98418, United States

Location

Novartis Investigator Site

Berlin, Germany

Location

Novartis Investigator Site

Kiel, Germany

Location

Novartis Investigator Site

Mönchengladbach, Germany

Location

Novartis Investigator Site

Munich, Germany

Location

Novartis Investigative Site

Neuss, Germany

Location

Novartis Investigative Site

Moscow, Russia

Location

Novartis Investigative Site

Saint Petersberg, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

canakinumabMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862 778 8300

Study Officials

  • NOVARTIS

    Novartis investigator site

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2008

First Posted

January 31, 2008

Study Start

December 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

February 13, 2012

Results First Posted

February 13, 2012

Record last verified: 2012-01

Locations

US(6)DE(5)RU(2)