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Trial record 1 of 1 for:    LANTUL07225
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Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan (NEWLAN)

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ClinicalTrials.gov Identifier: NCT02606357
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: INSULIN GLARGINE Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan
Actual Study Start Date : November 22, 2015
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : November 27, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Pharmaceutical form:Solution

Route of administration: Subcutaneous

Other Name: HOE901




Primary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: Baseline, 6 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02606357


Locations
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Jordan
JORDAN
Jordan, Jordan
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02606357     History of Changes
Other Study ID Numbers: LANTUL07225
U1111-1172-1002 ( Other Identifier: UTN )
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs