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Type 2 Diabetes MellitusPhase 3TITRATIONNCT02401243

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

A Phase 3 study testing INSULIN GLARGINE (U300) in people with Type 2 Diabetes Mellitus, run by Sanofi at 25 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
INSULIN GLARGINE (U300)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
253 participants
Where
25 sitesCanada
Study dates
Mar 2015to Feb 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

Canada25 sites

  • Investigational Site Number 124001

    Abbotsford British Columbia, V2S3N5

  • Investigational Site Number 124013

    Brampton, L6T4V3

  • Investigational Site Number 124008

    Burlington

  • Investigational Site Number 124024

    Burnaby, V5G1T4

  • Investigational Site Number 124015

    Collingwood, L9Y1W3

  • Investigational Site Number 124025

    Corunna, N0N 1G0

  • Investigational Site Number 124019

    Etobicoke, M9V4V4

  • Investigational Site Number 124021

    Hamilton

  • Investigational Site Number 124011

    Laval, H7T 2P5

  • Investigational Site Number 124005

    Lévis, G6W5M6

  • Investigational Site Number 124018

    London, N5W 6A2

  • Investigational Site Number 124003

    Oshawa

  • Investigational Site Number 124010

    Québec, G1W4R4

  • Investigational Site Number 124012

    Québec

  • Investigational Site Number 124007

    Sarnia, N7T 4R9

  • Investigational Site Number 124002

    Saskatoon, S7K 3H3

  • Investigational Site Number 124023

    Sherbrooke, J1G5K2

  • Investigational Site Number 124009

    Smiths Falls, K7A4W8

  • Investigational Site Number 124017

    Strathroy, N7G1Y7

  • Investigational Site Number 124020

    Toronto, M8V3X8

  • Investigational Site Number 124006

    Vancouver, V5Z1M9

  • Investigational Site Number 124026

    Vancouver, V6J1S3

  • Investigational Site Number 124004

    Victoria, V8V4H1

  • Investigational Site Number 124014

    Winnipeg, R2V4W3

  • Investigational Site Number 124016

    Winnipeg, R3E 3P4

Other trials in Canada

About this study

Official title: A Pilot Descriptive Canadian, Multicenter, Open-label, Randomized Study of Two Titration Algorithms With Insulin Glargine 300 Units/mL in Type 2 Diabetes Mellitus Patients

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.

Read more

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.

Read the detailed description

The total study duration is approximately 14 weeks (2 weeks screening and 12 weeks treatment) with a 2-day safety follow-up and a study extension of 12 weeks for eligible patients.

Being tested
INSULIN GLARGINE (U300)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INSULIN GLARGINE (U300)Drug

    Also called HOE901

    Pharmaceutical form: pre-filled disposable pen

    Route of administration: subcutaneous

Study groups in NCT02401243
Study groupRoleWhat they receive
Cohort 1 (INSIGHT titration algorithm)ExperimentalINSULIN 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
Receives: Drug: INSULIN GLARGINE (U300)
Cohort 2 (EDITION titration algorithm)ExperimentalINSULIN 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
Receives: Drug: INSULIN GLARGINE (U300)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 weeks

Secondary outcomes (1)

  1. Percentage of patients with adverse events

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02401243
Sponsor's protocol ID
GLARGL07496
Other IDs
U1111-1168-5158
Acronym
TITRATION
Status last verified
Mar 2016
First submitted
24 Mar 2015
Last updated
28 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing INSULIN GLARGINE (U300) in people with Type 2 Diabetes Mellitus, run by Sanofi at 25 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients reaching fasting SMPG ≤5.6 mmol/L without nocturnal (midnight to 6:00 am) hypoglycemia (confirmed or symptomatic or severe) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02401243.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2016.

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