The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India. The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Administered SC
Administered SC
Osmania Medical College & Hospital
Hyderabad, Andhra Pradesh, India
King George Hospital, Visakhapatnam
Visakhapatnam, Andhra Pradesh, India
Diabetes Research Centre
Royapuram, Chennai India, India
Percentage of Participants with at least 1 Episode of Hypoglycemia
Percentage of participants with at least 1 episode of hypoglycemia will be reported.
Time frame: Baseline through Week 26
Percentage of Participants with Severe Hypoglycemic Events
Percentage of participants with severe hypoglycemic events defined as (events/participants/year).
Time frame: Week 26
Percentage of Participants with Nocturnal Hypoglycemia Events
Percentage of participants with nocturnal hypoglycemia events defined as the incidence and rate (events/participant/year) of nocturnal hypoglycemia (BG\<54 mg/dL).
Time frame: Week 26
Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events
Percentage of participants with nocturnal and documented hypoglycemia events will be reported.
Time frame: Week 26
Change from Baseline to Week 26 in Body Weight
Change from baseline to week 26 in body weight will be reported.
Time frame: Baseline, Week 26
Change from Baseline to Week 26 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score
The ITSQ is a 22-item, participant-completed questionnaire that assesses insulin treatment satisfaction over the past 4 weeks for participants with diabetes in 5 domains: Inconvenience of Regimen (5 items), Lifestyle Flexibility (3 items), Glycemic Control (3 items), Hypoglycemic Control (5 items), Insulin Delivery Device Satisfaction (6 items). Participants respond to each item on a 7-point Likert scale ranging from "not at all" to "extremely." Scores can be generated for each domain and the overall score is transformed to a scale of 0-100. Higher scores indicate better treatment satisfaction.
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Vijyaratna Dibetes Diagnosis Treatment Centre
Ahmedabad, Gujarat, India
Center for Diabetes and Endocrine Care
Bengaluru, Karnataka, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India
Chellaram Diabetes Institute
Pune, Maharashtra, India
S. P. Medical College & A G Hospital
Bikaner, Rajasthan, India
Rajasthan University of Health Sciences
Jaipur, Rajasthan, India
Kovai Diabetes Speciality Center and Hospital
Coimbatore, Tamil Nadu, India
...and 2 more locations
Time frame: Baseline, Week 26
Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c)
Change from baseline to week 26 in HbA1c will be reported.
Time frame: Baseline, Week 26
Percentage of Participants Achieving HbA1c Less Than (<) 7%
Percentage of participants achieving HbA1c \<7% will be reported.
Time frame: Week 26
Change from Baseline to Week 26 in 1- and 2-hour Postprandial Glucose (PPG) Values
1- and 2-hour PPG values are estimated from self-monitored blood glucose (SMBG)
Time frame: Baseline, Week 26
Change from Baseline to Week 26 in Bolus Insulin Dose
Change from Baseline to Week 26 in Bolus Insulin Dose will be reported.
Time frame: Baseline, Week 26
Change from Baseline to Week 26 in Basal Insulin Dose
Change from Baseline to Week 26 in Basal Insulin Dose will be reported.
Time frame: Baseline, Week 26
Change from Baseline to Week 26 in Bolus Basal: Bolus Ratio
Change from Baseline to Week 26 in Basal: Bolus Ratio will be reported.
Time frame: Baseline, Week 26
Change from Baseline to Week 26 in 9-Point Self-Monitored Blood Glucose (SMBG) Values
SMBG measurements were taken at 9 time points: fasting, 1 hour post breakfast, 2 hours post breakfast, pre lunch,1 hour post lunch, 2 hours post lunch, pre dinner, 1 hour post dinner, and 2 hours post dinner.
Time frame: Baseline, Week 26