ACZ885 in Type 1 Diabetes Mellitus
This study has been withdrawn prior to enrollment.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01322321
First received: March 22, 2011
Last updated: September 4, 2012
Last verified: September 2012
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Purpose
This study will assess the safety and efficacy of ACZ885 on stimulated C-peptide during a mixed meal test in patients with newly-diagnosed type 1 diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Diabetes Type 1 |
Drug: ACZ885 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Multiple-dose, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ACZ885 in Patients With Newly Diagnosed Type-1 Diabetes Mellitus (T1DM) |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 13 months [ Time Frame: at 13 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Measure: Change from baseline of stimulated C-peptide after a mixed meal tolerance test at 4, 7, 10, 18, 24, 30 and 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Measure: Change from baseline of fasted C-peptide at 4, 7, 10, 13, 18, 24, 30 and 36 months [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Measure: number of hypoglycemic events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Measure: daily insulin dose [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Measure: anti-ACZ885 antibodies [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | March 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ACZ885 | Drug: ACZ885 |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 6 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- diagnosis of type 1 diabetes within 3 months of visit 1 and on a stable insulin regimen
- presence of at least one diabetes-related autoantibody
- qualifying C-peptide value in a mixed meal test at visit 1
- willing to not have vaccination with a live vaccine for 18 months, from 3 months before visit 1 until 3 months after the last dose of study drug
- body weight of at least 30 kg
Exclusion Criteria:
- women of child-bearing potential unless a highly effective method of birth control is used (such as combined oral contraceptives, intrauterine devices, etc)
- immunodeficiency
- active infections or febrile illness within 3 days before visit 1
- major dental work within 8 days before visit 1
- positive test for tuberculosis at visit 1
- use of medications other than insulin for the treatment of diabetes Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322321
Locations
| United States, Wisconsin | |
| Aurora St Luke's Medical Center, Endocrine & Diabetes Center | |
| Milwaukee, Wisconsin, United States | |
| Canada, Ontario | |
| LMC Endocrinology Centres (Barrie) Ltd | |
| Barrie, Ontario, Canada | |
| LMC Endocrinology Centres (Bayview) Ltd | |
| Toronto, Ontario, Canada | |
| Germany | |
| Novartis Investigative Site | |
| Dusseldorf, Germany | |
| Novartis Investigative Site | |
| Hannover, Germany | |
| Novartis Investigative Site | |
| Neuwied, Germany | |
| United Kingdom | |
| Novartis Investigative Site | |
| Bristol, United Kingdom | |
| Novartis Investigative Site | |
| Exeter, United Kingdom | |
| Novartis Investigative Site | |
| Hull, United Kingdom | |
| Novartis Investigative Site | |
| Liverpool, United Kingdom | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01322321 History of Changes |
| Other Study ID Numbers: | CACZ885I2208, 2010-020166-20 |
| Study First Received: | March 22, 2011 |
| Last Updated: | September 4, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Germany: Paul-Ehrlich-Institut United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
ACZ885 diabetes type 1 C-peptide |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013