Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 20 of 20

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks	Baseline, 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.	percentage of HbA1c	LEAST_SQUARES_MEAN
SECONDARY	Total Hypoglycemia Rates (Adjusted for 30 Days)	Baseline through 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.	episodes/participant/30 days	MEAN
SECONDARY	Percentage of Participants With Total Hypoglycemia Episodes	Baseline through 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.	percentage of participants	NUMBER
SECONDARY	Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)	Baseline through 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.	events/participant/30 days	MEAN
SECONDARY	Percentage of Participants With Nocturnal Hypoglycemia Episodes	Baseline through 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.	percentage of participants	NUMBER
SECONDARY	Body Weight Change From Baseline to 26 Weeks	Baseline, 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.	kilograms (kg)	LEAST_SQUARES_MEAN
SECONDARY	Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks	26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks	up to 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks	up to 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.	percentage of participants	NUMBER
SECONDARY	Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks	26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.	units/kg/day	LEAST_SQUARES_MEAN
SECONDARY	Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks	26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks	26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	0300-hour Blood Glucose to FBG Excursion at 26 Weeks	26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at baseline and post-baseline.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	HbA1c at 26 Weeks	26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.	percentage of HbA1c	LEAST_SQUARES_MEAN
SECONDARY	Lipid Profile at 26 Weeks	26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks	Baseline through 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline.	participants	NUMBER
SECONDARY	Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks	up to 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Low Blood Sugar Survey (LBSS) at 26 Weeks	26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	EuroQoL-5D (EQ-5D) at 26 Weeks	up to 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable EQ-5D data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Rapid Assessment of Physical Activity (RAPA) at 26 Weeks	up to 26 weeks	Participants who were randomized, had at least 1 dose of study medication, and had evaluable RAPA data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.	percentage of participants	NUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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