Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients

NCT02401243 | Completed Phase 3

• 2 other identifiers: GLARGL07496U1111-1168-5158
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 25

Brief Summary

Primary Objective: The primary objective of this study is to obtain efficacy and safety descriptive data on 2 different titration algorithms: the INSIGHT titration algorithm (self-titration of 1 unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL when given as basal insulin in uncontrolled type 2 diabetes mellitus (T2DM) patients on basal insulin with or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients. Secondary Objective: The secondary objective is to gain additional efficacy and safety data (glycated hemoglobin \[A1C\], fasting plasma glucose \[FPG\], 7-point self-measure plasma glucose \[SMPG\], insulin dose and weight) and determine patient related outcome and health care professional satisfaction as it pertains to each titration regimen.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Percentage of patients reaching fasting SMPG ≤5.6 mmol/L without nocturnal (midnight to 6:00 am) hypoglycemia (confirmed or symptomatic or severe)

  12 weeks

Secondary Outcomes (1)

• Percentage of patients with adverse events

  12 weeks

Study Arms (2)

Cohort 1 (INSIGHT titration algorithm)

EXPERIMENTAL

INSULIN GLARGINE (U300): self-titration of insulin glargine 300 units/mL (U300) will be increased daily by 1 unit until fasting SMPG reaches the target range of 4.4 to 5.6 mmol/L

Drug: INSULIN GLARGINE (U300)

Cohort 2 (EDITION titration algorithm)

EXPERIMENTAL

INSULIN GLARGINE (U300): titration of insulin glargine 300 units/mL (U300) will be adjusted weekly or not more than every 3 days to achieve the target range of fasting SMPG of 4.4 to 5.6 mmol/L

Drug: INSULIN GLARGINE (U300)

Interventions

INSULIN GLARGINE (U300) DRUG

Pharmaceutical form: pre-filled disposable pen Route of administration: subcutaneous

Also known as: HOE901

Cohort 1 (INSIGHT titration algorithm); Cohort 2 (EDITION titration algorithm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 2 diabetes mellitus.
• Patients who are ≥18 years of age.
• Treated for diabetes for at least 6 months.
• If on basal insulin, stable for at least 3 months prior to screening visit on their basal insulin treatment(s) (±20% total insulin dose)
• If on NIAHA, stable for at least 8 weeks prior to screening visit on their NIAHA(s) (no change in dose or initiation of new NIAHAs).
• Patients on uncontrolled basal insulin (insulin glargine, normal protamine Hagedorn \[NPH\], detemir) +/ NIAHAs with an A1c \>7.0% and ≤10% or uncontrolled on NIAHAs (insulin naïve patients) with an A1c \>7.0% and ≤11%.
• Signed informed consent form.

You may not qualify if:

• Patients with type 1 diabetes mellitus (T1DM).
• Nightshift worker.
• Female patients who are pregnant or lactating.
• Treatment with an insulin other than basal insulin (premixes, rapid insulin, fast acting insulin analogues) within the previous 3 months.
• Patients with less than 1 year history of diabetes.
• Patients unwilling to inject insulin or perform self-monitoring blood glucose.
• Current alcohol or drug abuse.
• Patients unlikely to comply with the protocol and complete the study eg, uncooperative attitude, inability to return for follow-up visits.
• Patients with active cancer or any other diseases or conditions which in the opinion of the Investigator would make the patient unsuitable for participation in the study.
• Any clinically significant laboratory findings that in the judgment of the Investigator would preclude safe completion of the study.
• Known allergies to study drugs.
• Participation in another clinical study.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (25)

Investigational Site Number 124001

Abbotsford, V2S3N5, Canada

Location

Investigational Site Number 124013

Brampton, L6T4V3, Canada

Location

Investigational Site Number 124008

Burlington, Canada

Location

Investigational Site Number 124024

Burnaby, V5G1T4, Canada

Location

Investigational Site Number 124015

Collingwood, L9Y1W3, Canada

Location

Investigational Site Number 124025

Corunna, N0N 1G0, Canada

Location

Investigational Site Number 124019

Etobicoke, M9V4V4, Canada

Location

Investigational Site Number 124021

Hamilton, Canada

Location

Investigational Site Number 124011

Laval, H7T 2P5, Canada

Location

Investigational Site Number 124005

Lévis, G6W5M6, Canada

Location

Investigational Site Number 124018

London, N5W 6A2, Canada

Location

Investigational Site Number 124003

Oshawa, Canada

Location

Investigational Site Number 124010

Québec, G1W4R4, Canada

Location

Investigational Site Number 124012

Québec, Canada

Location

Investigational Site Number 124007

Sarnia, N7T 4R9, Canada

Location

Investigational Site Number 124002

Saskatoon, S7K 3H3, Canada

Location

Investigational Site Number 124023

Sherbrooke, J1G5K2, Canada

Location

Investigational Site Number 124009

Smiths Falls, K7A4W8, Canada

Location

Investigational Site Number 124017

Strathroy, N7G1Y7, Canada

Location

Investigational Site Number 124020

Toronto, M8V3X8, Canada

Location

Investigational Site Number 124006

Vancouver, V5Z1M9, Canada

Location

Investigational Site Number 124026

Vancouver, V6J1S3, Canada

Location

Investigational Site Number 124004

Victoria, V8V4H1, Canada

Location

Investigational Site Number 124014

Winnipeg, R2V4W3, Canada

Location

Investigational Site Number 124016

Winnipeg, R3E 3P4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: March 27, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 28, 2016

Record last verified: 2016-03

Locations

CA (25)