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Phase 3 Completed N=1,369 Randomized Quadruple-blind Treatment

A Study in Participants With Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT01468987 ↗
Enrolled (actual)
1,369
Serious AEs
10.4%
Results posted
Apr 2018
Primary outcomePrimary: Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks — -1.66; -1.45 percentage of HbA1c

Summary

The purpose of this study is: * To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment. * To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment. * To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment. * To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks
-1.66; -1.45
SECONDARY
Total Hypoglycemia Rates (Adjusted for 30 Days)
5.97; 5.42
SECONDARY
Percentage of Participants With Total Hypoglycemia Episodes
95.2; 96.6
SECONDARY
Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)
0.51; 0.92
SECONDARY
Percentage of Participants With Nocturnal Hypoglycemia Episodes
59.5; 74.0
SECONDARY
Body Weight Change From Baseline to 26 Weeks
1.25; 2.21
SECONDARY
Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks
137.31; 133.81; 162.77; 156.41; 130.02; 133.63
SECONDARY
Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks
44.4; 32.6; 63.3; 53.3
SECONDARY
Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks
23.7; 12.2
SECONDARY
Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks
0.68; 0.60; 0.61; 0.63; 1.27; 1.21
SECONDARY
Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks
125.33; 132.02
SECONDARY
Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks
28.67; 33.54
SECONDARY
0300-hour Blood Glucose to FBG Excursion at 26 Weeks
-11.95; -15.16
SECONDARY
HbA1c at 26 Weeks
6.76; 6.97
SECONDARY
Lipid Profile at 26 Weeks
177.17; 174.79; 46.44; 47.71; 97.87; 98.89
SECONDARY
Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks
152; 161
SECONDARY
Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks
77.01; 77.29
SECONDARY
Low Blood Sugar Survey (LBSS) at 26 Weeks
21.44; 21.67
SECONDARY
EuroQoL-5D (EQ-5D) at 26 Weeks
0.86; 0.85
SECONDARY
Rapid Assessment of Physical Activity (RAPA) at 26 Weeks
2.2; 2.4; 4.6; 6.2; 21.9; 18.0

Eligibility Criteria

Inclusion Criteria

  • Have type 2 diabetes mellitus based on the World Health Organization (WHO) classification
  • Had diabetes ≥1 year
  • Have a hemoglobin A1c (HbA1c) value ≥7.0% and 4.5 millimoles per liter [mmol/L], >400 milligrams per deciliter [mg/dL]) at screening
  • Are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications for weight loss
  • Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to entry into the study
  • Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the 6 months prior to screening
  • Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening
  • Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association Cardiac Disease Classification)
  • Are currently receiving renal dialysis or have a serum creatinine ≥2.0 mg/dL, except for participants taking metformin who will be required to follow local labeling restrictions regarding metformin use and serum creatinine
  • Have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD], acute or chronic hepatitis, non-alcoholic steatohepatitis [NASH], or elevated liver enzyme measurements as indicated below:
  • total bilirubin ≥2X the upper limit of normal (ULN) as defined by the central laboratory, or
  • alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) >2.5X ULN as defined by the central laboratory, or
  • aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) >2.5X ULN as defined by the central laboratory
  • Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
  • Have known or develop hypersensitivity or allergy to any of the study insulins or their excipients
  • Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c measurement
  • Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, and inhaled preparations) or have received such therapy within 8 weeks immediately before screening with the exception of replacement therapy for adrenal insufficiency
  • Diagnosed clinically significant diabetic autonomic neuropathy, in the opinion of the investigator
  • Have had an organ transplant
  • Have any other condition (including known drug or alcohol abuse or psychiatric disorder including eating disorder) that precludes the participant from following and completing the protocol
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01468987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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