Trial Outcomes & Findings for The LANCET Trial: A Trial of Long-acting Insulin Injection to Reduce C-reactive Protein in Patients With Type 2 Diabetes (NCT NCT00366301)
NCT ID: NCT00366301
Last Updated: 2010-11-25
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
500 participants
Primary outcome timeframe
14 weeks
Results posted on
2010-11-25
Participant Flow
Recruitment occurred at 73 US office-based practices between October 2006 and December 2008.
Preenrollment evaluation comprised local laboratory testing of hsCRP,HbA1c, and safety parameters (ALT or AST and creatinine). Eligible participants were enrolled in a 2-week run-in. Ability to self-monitor fingerstick blood glucose and perform insulin injection was determined and evaluation for evidence of marked hyperglycemia was undertaken.
Participant milestones
| Measure |
Placebo Pill
Placebo pill
|
Metformin Pill
Metformin pill
|
Insulin Glargine Plus Placebo Pill
Insulin glargine plus placebo pill
|
Insulin Glargine Plus Metformin Pill
Insulin Glargine plus metformin pill
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
124
|
126
|
126
|
124
|
|
Overall Study
Either 6W or 14W CRP Obtained
|
120
|
124
|
124
|
119
|
|
Overall Study
COMPLETED
|
116
|
120
|
122
|
116
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
4
|
8
|
Reasons for withdrawal
| Measure |
Placebo Pill
Placebo pill
|
Metformin Pill
Metformin pill
|
Insulin Glargine Plus Placebo Pill
Insulin glargine plus placebo pill
|
Insulin Glargine Plus Metformin Pill
Insulin Glargine plus metformin pill
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
3
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
1
|
1
|
Baseline Characteristics
The LANCET Trial: A Trial of Long-acting Insulin Injection to Reduce C-reactive Protein in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Placebo Pill
n=124 Participants
Placebo pill
|
Metformin Pill
n=126 Participants
Metformin pill
|
Insulin Glargine Plus Placebo Pill
n=126 Participants
Insulin glargine plus placebo pill
|
Insulin Glargine Plus Metformin Pill
n=124 Participants
Insulin Glargine plus metformin pill
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
Mean (SD)
|
54.0 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
54.0 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
53.9 years
STANDARD_DEVIATION 11.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
281 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
219 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
438 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
91 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
365 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
25 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 14 weeksPopulation: As hsCRP was measured at both 6 and 14 weeks, linear mixed models conditioning on baseline hsCRP and adjusting for treatment stratum were constructed with the dependent variable being change in lnCRP. Any subject having either or both 6 week and 14 week measures was included.
Outcome measures
| Measure |
Placebo Pill
n=120 Participants
Placebo pill
|
Metformin Pill
n=124 Participants
Metformin pill
|
Insulin Glargine Plus Placebo Pill
n=124 Participants
Insulin glargine plus placebo pill
|
Insulin Glargine Plus Metformin Pill
n=119 Participants
Insulin Glargine plus metformin pill
|
|---|---|---|---|---|
|
Percentage Reduction in C-reactive Protein (CRP)
|
-19.0 Percent CRP Reduction
Interval -27.8 to -9.1
|
-16.1 Percent CRP Reduction
Interval -25.1 to -6.1
|
-2.9 Percent CRP Reduction
Interval -13.2 to 8.6
|
-20.1 Percent CRP Reduction
Interval -28.8 to -10.4
|
Adverse Events
Placebo Pill
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Metformin Pill
Serious events: 8 serious events
Other events: 18 other events
Deaths: 0 deaths
Insulin Glargine Plus Placebo Pill
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Insulin Glargine Plus Metformin Pill
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Pill
n=124 participants at risk
Placebo pill
|
Metformin Pill
n=126 participants at risk
Metformin pill
|
Insulin Glargine Plus Placebo Pill
n=126 participants at risk
Insulin glargine plus placebo pill
|
Insulin Glargine Plus Metformin Pill
n=124 participants at risk
Insulin Glargine plus metformin pill
|
|---|---|---|---|---|
|
Cardiac disorders
Supraventricular Tachycardia Requiring Hospitalization
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.79%
1/126 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Gastrointestinal disorders
Severe Diarrhea Requiring Hospitalization
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.79%
1/126 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Endocrine disorders
Hyperglycemia Requiring Hospitalization
|
0.81%
1/124 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Infections and infestations
Cellulitis Hospitalization
|
0.81%
1/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Infections and infestations
Sepsis Hospitazation
|
0.81%
1/124 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Gastrointestinal disorders
Gastroenteritis Hospitalization
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
1.6%
2/126 • Number of events 2 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Cardiac disorders
Chest Pain Hospitalization
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
1.6%
2/126 • Number of events 2 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.79%
1/126 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Musculoskeletal and connective tissue disorders
Traumatic Injury/Fracture
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.79%
1/126 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Psychiatric disorders
Depression
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.79%
1/126 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Renal and urinary disorders
Nephrolithiasis Requiring Hospitalization
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.79%
1/126 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/124 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
Other adverse events
| Measure |
Placebo Pill
n=124 participants at risk
Placebo pill
|
Metformin Pill
n=126 participants at risk
Metformin pill
|
Insulin Glargine Plus Placebo Pill
n=126 participants at risk
Insulin glargine plus placebo pill
|
Insulin Glargine Plus Metformin Pill
n=124 participants at risk
Insulin Glargine plus metformin pill
|
|---|---|---|---|---|
|
Endocrine disorders
Severe Hypoglycemia
|
0.81%
1/124 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
2.4%
3/126 • Number of events 3 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
2.4%
3/126 • Number of events 3 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
4.8%
6/124 • Number of events 6 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Endocrine disorders
Hyperglycemia: Confirmed Fasting Glucose >= 250 mg/dl
|
8.1%
10/124 • Number of events 10 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.79%
1/126 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
3.2%
4/126 • Number of events 4 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.81%
1/124 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Endocrine disorders
Hyperglycemia: Any Self-Monitor Blood Glucose >= 400 mg/dl
|
2.4%
3/124 • Number of events 3 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.00%
0/126 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
2.4%
3/126 • Number of events 3 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
0.81%
1/124 • Number of events 1 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Endocrine disorders
Weight Gain >= 5% of Baseline
|
2.4%
3/124 • Number of events 3 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
3.2%
4/126 • Number of events 4 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
11.1%
14/126 • Number of events 14 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
6.5%
8/124 • Number of events 8 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
|
Gastrointestinal disorders
Gastrointestinal Adverse Event (e.g. diarrhea not requiring hospitalization)
|
2.4%
3/124 • Number of events 3 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
10.3%
13/126 • Number of events 13 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
3.2%
4/126 • Number of events 4 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
6.5%
8/124 • Number of events 8 • 14 weeks
Occurrence of marked hypoglycemia, weight gain, and other adverse events were collected at each of 6 visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place