A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT03736785|
Recruitment Status : Completed
First Posted : November 9, 2018
Last Update Posted : March 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: LY3209590 Drug: Insulin Degludec||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||394 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin|
|Actual Study Start Date :||November 15, 2018|
|Actual Primary Completion Date :||February 18, 2020|
|Actual Study Completion Date :||February 18, 2020|
Experimental: LY3209590 Algorithm 1
LY3209590 administered subcutaneously (SC).
Experimental: LY3209590 Algorithm 2
LY3209590 administered SC.
Experimental: Insulin Degludec
Insulin degludec administered SC.
Drug: Insulin Degludec
- Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 32 ]Change from baseline in HbA1c
- Change from Baseline in HbA1c Compared to Insulin Degludec [ Time Frame: Baseline, Week 32 ]Change from baseline in HbA1c compared to insulin degludec
- Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 32 ]Change from baseline in fasting glucose
- Change from Baseline in Insulin Dose [ Time Frame: Baseline, Week 32 ]Change from baseline in insulin dose
- Rate of Total Documented Symptomatic Hypoglycemia [ Time Frame: Week 32 ]Rate of total documented symptomatic hypoglycemia
- Change from Baseline in Body Weight [ Time Frame: Baseline, Week 32 ]Change from baseline in body weight
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 [ Time Frame: Week 32 ]PK: AUC of LY3209590
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): NCT03736785
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5hours, EST)||Eli Lilly and Company|