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
-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).
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||242 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels
Drug: INSULIN GLARGINE
Route of administration: Subcutaneous
Other Name: HOE901
- Change from baseline in HbA1c [ Time Frame: Baseline, 6 months ]
- - Percentage of patients achieving target of HbA1c <7% [ Time Frame: 6 months ]
- - Change from baseline in fasting plasma glucose values [ Time Frame: Baseline, 3 months, and 6 months ]
- - Percentage of patients with hypoglycemic events [ Time Frame: Baseline, 6 months ]
- - Change from baseline in body weight [ Time Frame: Baseline, 3 months and 6 months ]
- - Number of patients with adverse events [ Time Frame: Baseline, 6 months ]
- - Change in dose of insulin glargine [ Time Frame: 3 months and 6 months ]
- - Change in the titration doses used (if any) [ Time Frame: 6 months ]
- - Time to reach control [ Time Frame: 6 months ]
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
|Study Director:||Clinical Sciences & Operations||Sanofi|