| Trial ID: | L3686 |
| Source ID: | NCT05331469
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| Associated Drug: |
Nph Basal Insulin Titration
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| Title: |
Difference of Basal Insulin Titration Method in Reducing HbA1c Among Type 2 Diabetes Mellitus (T2DM) Patients.
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| Acronym: |
|
| Status: |
UNKNOWN
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
to Identify Which Titration Regimen of Basal Insulin (Being Daily Titration vs 3 Daily Titration) is Better in Reducing hba1c and Have Lesser Hypoglycemia
|
| Interventions: |
DRUG: NPH basal insulin titration
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| Outcome Measures: |
Primary: Hba1c reduction, To compare the HbA1c reduction of the daily basal insulin titration arm with the 3-daily basal insulin titration arm, 3 months | Secondary: percentage of subjects achieving fasting capillary blood glucose and/or hba1c below 7%, To compare the percentage of patient achieving fasting blood glucose within 4.4-7mmol/L and/or HbA1c below 7% between the daily basal insulin titration arm with the 3-daily basal insulin titration arm within the study period, 3 months|Hypoglycemia frequency, To compare the frequency of hypoglycemia between the daily basal insulin titration arm with the 3- daily basal insulin titration arm, 3 months|Basal insulin required to achieve fasting blood sugar less than 7mmol/L, To compare the total basal insulin dosage required to achieve normal fasting CBG 4.4-7.0mmol/L between the daily basal insulin titration arm with the 3-daily basal insulin titration arm, 3 months|Duration to achieve fasting cappilary blood glucose less than 7mmol/L, To compare the duration taken to achieve normal fasting CBG 4.4-7.0mmol/L between the daily basal insulin titration arm with the 3-daily basal insulin titration arm, 3 months|Satisfaction of titration, To compare the satisfaction to the titration method between the daily basal insulin titration arm with the 3-daily basal insulin titration arm, 3 months|Weight changes after intervention, To compare with weight changed between the daily basal insulin titration arm with the 3-daily basal insulin titration arm, 3 months
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| Sponsor/Collaborators: |
Sponsor: University of Malaya
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
70
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2021-07-19
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| Completion Date: |
2023-04-30
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| Results First Posted: |
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| Last Update Posted: |
2022-04-15
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| Locations: |
University Malaya Medical Centre, Kuala Lumpur, Malaysia
|
| URL: |
https://clinicaltrials.gov/show/NCT05331469
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