CClinicalTrials.gg
CompletedNCT02606357NEWLANUpdated Oct 12, 2018

Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan

A Phase 4 interventional study of INSULIN GLARGINE in Diabetes Mellitus, Type 2, sponsored by Sanofi. Completed at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-12.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
242
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Primary Objective:

-To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine).

Secondary Objectives:

  • To evaluate the percentage of patients achieving target of HbA1c ˂7%.
  • To evaluate the change in fasting plasma glucose (FPG).
  • To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety.
  • Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.
Read the detailed description

The total duration of study period per patient is up to 6 months.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 242 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient ≥ 18 years old.
  • Male or Female.
  • Type 2 diabetes patients.
  • Uncontrolled with previous therapy (HbA1c >7%), evident in HbA1c test within the last 1 month before study entry.
  • Insulin naïve patients: any patient uncontrolled after one or a maximum of two lines of therapy including: monotherapy (Metformin alone or any other Oral Anti-Diabetic agent (OAD) if contraindicated or intolerance) and/or dual therapy (any OAD combination), at maximum tolerated dose in the last 3 months.
  • Signed informed consent.
  • Signed informed consent.

Exclusion criteria

Exclusion criteria:

  • Patient not willing or not able to perform self-monitoring blood glucose.
  • Patient not willing or not able to self-titrate insulin glargine under physician's guidance.
  • Patient not suitable for participation according to what is specified in the approved Summary of Product's Characteristics or according to medical or clinical conditions, as judged by the Investigator.
  • History of impaired hepatic function defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than three times the upper limit of normal, evident in testing done in the last 3 months.
  • History of impaired renal function defined as serum creatinine >135 μmol/L (>1.525 mg/dL)in men and >110 μmol/L (>1.243 mg/dL) in women, evident in testing done in the last 3 months.
  • Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method at physician's discretion).
  • Treatment with systemic corticosteroid within 3 months prior to study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
242 participants (actual)

Study arms

  • Experimental
    HOE901

    HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels

    Drug: INSULIN GLARGINE

Interventions

  • DrugINSULIN GLARGINE

    Pharmaceutical form:Solution Route of administration: Subcutaneous

    Also known as: HOE901

06

What researchers measure

Primary outcomes

  1. Change from baseline in HbA1c

    Time frame: Baseline, 6 months

Secondary outcomes

  1. - Percentage of patients achieving target of HbA1c <7%

    Time frame: 6 months

  2. - Change from baseline in fasting plasma glucose values

    Time frame: Baseline, 3 months, and 6 months

  3. - Percentage of patients with hypoglycemic events

    Time frame: Baseline, 6 months

  4. - Change from baseline in body weight

    Time frame: Baseline, 3 months and 6 months

  5. - Number of patients with adverse events

    Time frame: Baseline, 6 months

  6. - Change in dose of insulin glargine

    Time frame: 3 months and 6 months

  7. - Change in the titration doses used (if any)

    Time frame: 6 months

  8. - Time to reach control

    Time frame: 6 months

07

Study locations

1 site
  • JORDAN
    Jordan, Jordan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02606357
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Nov 17, 2015
Start date
Nov 22, 2015
Primary completion
Nov 27, 2017
Completion
Nov 27, 2017
Last update
Oct 12, 2018

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion