Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01885260
First received: June 13, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCGRRx in combination with metformin versus placebo + metformin


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: ISIS-GCGRRx - Dose Level 1
Drug: ISIS-GCGRRx - Dose Level 2
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin

Resource links provided by NLM:


Further study details as provided by Isis Pharmaceuticals:

Primary Outcome Measures:
  • The effect of ISIS-GCGRRx on serum fructosamine [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    Change from Baseline to Week 14


Secondary Outcome Measures:
  • The safety of ISIS-GCGRRx [ Time Frame: 25 Weeks ] [ Designated as safety issue: Yes ]
    By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations

  • The tolerability of ISIS-GCGRRx [ Time Frame: 25 Weeks ] [ Designated as safety issue: No ]
    By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations


Estimated Enrollment: 72
Study Start Date: July 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ISIS-GCGRRx Group 1 Drug: ISIS-GCGRRx - Dose Level 1
3 doses on alternate days during the first week and then once weekly for 12 weeks + daily metformin
Experimental: ISIS-GCGRRx Group 2 Drug: ISIS-GCGRRx - Dose Level 2
3 doses on alternate days during the first week and then once weekly for 12 weeks + daily metformin
Placebo Comparator: Placebo Drug: Placebo
3 doses on alternate days during the first week and then once weekly for 12 weeks + daily metformin

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age 18 to 75
  • BMI greater than or equal to 25
  • HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
  • Type 2 Diabetes Mellitus and on stable dose of oral metformin
  • Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

  • Clinically significant abnormalities in medical history or physical exam
  • Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
  • History of renal transplantation or renal dialysis
  • History of liver disease
  • History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
  • Use of oral anti-diabetic medication other than metformin within 3 months of screening
  • History of diabetic ketoacidosis
  • Any other significant illness or condition that may interfere with the patient participating or completing the study
  • Inability or unwillingness to comply with protocol or study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885260

Locations
United States, Alabama
Isis Investigational Site
Birmingham, Alabama, United States, 35216
Isis Investigational Site
Muscle Shoals, Alabama, United States, 35662
United States, California
Isis Investigational Site
Anaheim, California, United States, 92801
Isis Investigational Site
Chino, California, United States, 91710
Isis Investigational Site
Los Angeles, California, United States, 90057
United States, Florida
Isis Investigational Site
Deland, Florida, United States, 32720
Isis Investigational Site
Ft. Lauderdale, Florida, United States, 33306
Isis Investigational Site
Miami, Florida, United States, 33143
United States, Georgia
Isis Investigational Site
Marietta, Georgia, United States, 30066
United States, Nevada
Isis Investigational Site
Las Vegas, Nevada, United States, 89101
United States, Ohio
Isis Investigational Site
Cincinnati, Ohio, United States, 45245
United States, Oklahoma
Isis Investigational Site
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Isis Investigational Site
Eugene, Oregon, United States, 97404
United States, Texas
Isis Investigational Site
Corpus Christi, Texas, United States, 78404
Isis Investigational Site
Katy, Texas, United States, 77450
United States, Utah
Isis Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Washington
Isis Investigational Site
Renton, Washington, United States, 98057
Isis Investigational Site
Spokane, Washington, United States, 99202
South Africa
Isis Investigational Site
Lenasia South, Gauteng, South Africa, 1829
Isis Investigational Site
Soweto, Gauteng, South Africa, 1818
Isis Investigational Site
Durban, KwaZulu-Natal, South Africa, 4091
Isis Investigational Site
Cape Town, Western Cape, South Africa, 7700
Isis Investigational Site
Parow, Cape Town, Western Cape, South Africa, 7500
Isis Investigational Site
Western Cape, South Africa, 7130
Sponsors and Collaborators
Isis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Isis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01885260     History of Changes
Other Study ID Numbers: ISIS 449884-CS2
Study First Received: June 13, 2013
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council

Keywords provided by Isis Pharmaceuticals:
Type 2 Diabetes Mellitus
T2DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014