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OpenTrials
Completed

NCT Number: NCT02606357

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

JORDAN

Jordan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

insulin glargine

Drug

Pharmaceutical form:Solution

Route of administration: Subcutaneous

Other names: HOE901

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan

Acronym: NEWLAN

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2015
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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