| Trial ID: | L1793 |
| Source ID: | NCT01486966
|
| Associated Drug: |
Insulin Detemir
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| Title: |
Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes
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| Acronym: |
|
| Status: |
TERMINATED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01486966/results
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| Conditions: |
Diabetes|Diabetes Mellitus, Type 2
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| Interventions: |
DRUG: insulin detemir|DRUG: insulin aspart|DRUG: insulin NPH|DRUG: human soluble insulin|DRUG: metformin
|
| Outcome Measures: |
Primary: Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment, Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile., Week 0, week 2 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment, The FPG referred to pre-breakfast plasma glucose., Week 0, week 2|Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment, The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal., Week 0, week 2|Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment, The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime., Week 0, week 2|Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment, Week 2|Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment, Week 2|Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment, FPG target was \< 6.0 mmol / L, 2hPPG target was \< 8.0 mmol / L., Week 2|Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment, FPG target was \< 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included)., Week 2|Change From Baseline in Fructosamine After Two Weeks of Treatment, Week 0, week 2|Incidence of Hypoglycaemic Episodes, All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition. Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) \< 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value \< 3.1 mmol/l (56 mg/dl). A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal., Weeks 0-2
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| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
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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: |
58
|
| 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: |
2011-11
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| Completion Date: |
2012-06
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| Results First Posted: |
2013-06-17
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| Last Update Posted: |
2017-03-17
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| Locations: |
Novo Nordisk Investigational Site, Beijing, Beijing, 100034, China|Novo Nordisk Investigational Site, Chongqing, Chongqing, 400016, China|Novo Nordisk Investigational Site, Wuxi, Jiangsu, 214023, China|Novo Nordisk Investigational Site, Nanchang, Jiangxi, 330006, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200003, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200072, China
|
| URL: |
https://clinicaltrials.gov/show/NCT01486966
|
