Trials / Completed
CompletedNCT02606357
Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan
Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The total duration of study period per patient is up to 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INSULIN GLARGINE | Pharmaceutical form:Solution Route of administration: Subcutaneous |
Timeline
- Start date
- 2015-11-22
- Primary completion
- 2017-11-27
- Completion
- 2017-11-27
- First posted
- 2015-11-17
- Last updated
- 2018-10-12
Locations
1 site across 1 country: Jordan
Source: ClinicalTrials.gov record NCT02606357. Inclusion in this directory is not an endorsement.