NCT01968265

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at below P25 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2013

Typical duration for phase_2 type-2-diabetes-mellitus

Geographic Reach
3 countries

14 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

October 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

October 18, 2013

Last Update Submit

May 11, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusT2DM

Outcome Measures

Primary Outcomes (1)

  • The effect of ISIS-GCCRRx on serum fructosamine

    Change from Baseline to Week 7

    7 Weeks

Secondary Outcomes (2)

  • The safety of ISIS-GCCRRx

    18 Weeks

  • The tolerability of ISIS-GCCRRx

    18 Weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

ISIS-GCCRRx

ACTIVE COMPARATOR
Drug: ISIS-GCCRRx

Interventions

ISIS-GCCRRxDRUG

3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin

ISIS-GCCRRx
PlaceboDRUG

3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months of screening
  • History of diabetic ketoacidosis
  • Current or previous diagnosis of Gilbert's disease
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Isis Investigative Site

Red Deer, Alberta, Canada

Location

Isis Investigative Site

Penticton, British Columbia, Canada

Location

Isis Investigative Site

Cornwall, Ontario, Canada

Location

Isis Investigative Site

Courtice, Ontario, Canada

Location

Isis Investigative Site

Greater Sudbury, Ontario, Canada

Location

Isis Investigative Site

Montreal, Quebec, H2R1V6, Canada

Location

Isis Investigative Site

Bucharest, Bucharest, 010507, Romania

Location

Isis Investigative Site

Bucharest, Bucharest, 011794, Romania

Location

Isis Investigative site

Bucharest, Bucharest, 022441, Romania

Location

Isis Investigative Site

Cluj-Napoca, Cluj, 400349, Romania

Location

Isis Investigative Site

Bloemfontein, Free State, 9300, South Africa

Location

Isis Investigative Site

Benoni, Gauteng, 1501, South Africa

Location

Isis Investigative Site

Soweto, Gauteng, 1818, South Africa

Location

Isis Investigative Site

Somerset West, Western Cape, 7130, South Africa

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 24, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2015

Study Completion

May 1, 2015

Last Updated

May 13, 2015

Record last verified: 2015-05

Locations

RO(4)ZA(4)CA(6)