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Clinical Trial Details

Trial ID: L4942
Source ID: NCT04816890
Associated Drug: M1 Pram P037
Title: A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: M1 Pram P037|DRUG: Insulin lispro
Outcome Measures: Primary: Body weight change from baseline to week 16 of treatment, Change in body weight after 16 weeks of treatment, From week 0 to week 16 | Secondary: TIR [70-180] mg/dL., Time In Range \[70-180\] mg/dL change from baseline to week 16 of treatment as measured by CGM., From week 0 to week 16|%TIR [70-180] mg/dL., Percentage of Time In Range \[70-180\] mg/dL change from baseline to week 16 of treatment as measured by CGM., From week 0 to week 16|TIR [70-140] mg/dL., Time In Range \[70-140\] mg/dL change from baseline to week 16 of treatment as measured by CGM., From week 0 to week 16|%TIR [70-140] mg/dL., Percentage of Time In Range \[70-140\] mg/dL change from baseline to week 16 of treatment as measured by CGM., From week 0 to week 16|MeanG_24h, Average glucose over 24h change from baseline to week 16 of treatment, From week 0 to week 16|CVG_24h, Coefficient Of Variation of glucose over 24h change from baseline to week 16 of treatment., From week 0 to week 16|DistG_24h, Distance travelled over 24h change from baseline to week 16 of treatment, From week 0 to week 16|SDG_24h, Standard Deviation of all glucose values over 24h change from baseline to week 16 of treatment, From week 0 to week 16|HbA1c, HbA1c change from baseline to week 16 of treatment, From week 0 to week 16|Total Insulin doses, Change from baseline of total insulin doses, From week 0 to week 16|Prandial Insulin doses, Change from baseline of prandial (per meal), insulin doses, From week 0 to week 16|Basal Insulin doses, Change from baseline of basal insulin doses, From week 0 to week 16|Number of Adverse Events, Number of Adverse Events observed during the treatment period, From week 0 to week 16|Duration of Adverse Events, Duration of Adverse Events observed during the treatment period, From week 0 to week 16|Hypoglycaemic episodes, Number of Hypoglycemic episodes during the 16 weeks treatment period, From week 0 to week 16
Sponsor/Collaborators: Sponsor: Adocia
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 80
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-03-23
Completion Date: 2022-02-24
Results First Posted:
Last Update Posted: 2022-06-24
Locations: Profil Mainz GmbH & Co, Mainz, 55116, Germany|Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany
URL: https://clinicaltrials.gov/show/NCT04816890