Trial Outcomes & Findings for Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily (NCT NCT00634842)
NCT ID: NCT00634842
Last Updated: 2017-03-10
Results Overview
Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
244 participants
Primary outcome timeframe
week 20
Results posted on
2017-03-10
Participant Flow
69 sites in the United States of America (USA).
Subjects were randomised 1:1 to 2 FPG (fasting plasma glucose) titration targets. Insulin doses were self-titrated every three days based on self-measured FPG levels as follows: -3 units if FPG was below the lower limit of the target range, no change if FPG was within target range, and +3 units if FPG was above the upper limit of the target range.
Participant milestones
| Measure |
FPG 70-90 mg/dL
Aggressive FPG (fasting plasma glucose) titration target range group
|
FPG 80-110 mg/dL
Conventional FPG (fasting plasma glucose) titration target range group
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
122
|
|
Overall Study
COMPLETED
|
107
|
104
|
|
Overall Study
NOT COMPLETED
|
15
|
18
|
Reasons for withdrawal
| Measure |
FPG 70-90 mg/dL
Aggressive FPG (fasting plasma glucose) titration target range group
|
FPG 80-110 mg/dL
Conventional FPG (fasting plasma glucose) titration target range group
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Protocol Violation
|
8
|
4
|
|
Overall Study
Move to another state
|
1
|
0
|
|
Overall Study
Inclusion criteria were not met
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Lack of time and intolerance to drug
|
0
|
1
|
|
Overall Study
Discontinued due to injection
|
0
|
2
|
|
Overall Study
No need of study drug to treat diabetes
|
0
|
1
|
|
Overall Study
No wish to keep taking Avandia
|
0
|
1
|
|
Overall Study
Subject off study drug for too long
|
0
|
1
|
Baseline Characteristics
Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily
Baseline characteristics by cohort
| Measure |
FPG 70-90 mg/dL
n=122 Participants
Aggressive FPG (fasting plasma glucose) titration target range group
|
FPG 80-110 mg/dL
n=122 Participants
Conventional FPG (fasting plasma glucose) titration target range group
|
Total
n=244 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Fasting plasma glucose (FPG)
|
164.0 mg/dL
STANDARD_DEVIATION 43.1 • n=5 Participants
|
163.1 mg/dL
STANDARD_DEVIATION 40.4 • n=7 Participants
|
163.5 mg/dL
STANDARD_DEVIATION 41.7 • n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.0 percentage
STANDARD_DEVIATION 0.6 • n=5 Participants
|
7.9 percentage
STANDARD_DEVIATION 0.6 • n=7 Participants
|
8.0 percentage
STANDARD_DEVIATION 0.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: week 20Population: The intent-to-treat (ITT) population with non-missing HbA1c values at end of study, LOCF (last observation carried forward)
Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment
Outcome measures
| Measure |
FPG 70-90 mg/dL
n=112 Participants
Aggressive FPG (fasting plasma glucose) titration target range group
|
FPG 80-110 mg/dL
n=112 Participants
Conventional FPG (fasting plasma glucose) titration target range group
|
|---|---|---|
|
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%
|
64.3 percentage of participants
|
54.5 percentage of participants
|
SECONDARY outcome
Timeframe: week 20Population: The intent-to-treat (ITT) population with non-missing HbA1c values at end of study, LOCF (last observation carried forward)
Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment
Outcome measures
| Measure |
FPG 70-90 mg/dL
n=112 Participants
Aggressive FPG (fasting plasma glucose) titration target range group
|
FPG 80-110 mg/dL
n=112 Participants
Conventional FPG (fasting plasma glucose) titration target range group
|
|---|---|---|
|
Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%
|
41.1 percentage of participants
|
26.8 percentage of participants
|
SECONDARY outcome
Timeframe: week -2, week 20Population: The intent-to-treat (ITT), LOCF (last observation carried forward) population. One Subject in 70-90 group, however, had a missing baseline value, therefore, no change from baseline could be calculated.
Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20
Outcome measures
| Measure |
FPG 70-90 mg/dL
n=111 Participants
Aggressive FPG (fasting plasma glucose) titration target range group
|
FPG 80-110 mg/dL
n=112 Participants
Conventional FPG (fasting plasma glucose) titration target range group
|
|---|---|---|
|
Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline
|
-1.229 percentage point change
Standard Error 0.061
|
-0.958 percentage point change
Standard Error 0.061
|
SECONDARY outcome
Timeframe: weeks 0-20Population: The safety population consists of all subjects exposed to study drug.
Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows: * If subject was unable to treat himself: Major incidence. * If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence. * If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only.
Outcome measures
| Measure |
FPG 70-90 mg/dL
n=121 Participants
Aggressive FPG (fasting plasma glucose) titration target range group
|
FPG 80-110 mg/dL
n=122 Participants
Conventional FPG (fasting plasma glucose) titration target range group
|
|---|---|---|
|
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
All
|
333 number of events
|
227 number of events
|
|
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Major
|
1 number of events
|
0 number of events
|
|
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Minor
|
225 number of events
|
136 number of events
|
|
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Symptoms only
|
107 number of events
|
91 number of events
|
Adverse Events
FPG 70-90 mg/dL
Serious events: 5 serious events
Other events: 45 other events
Deaths: 0 deaths
FPG 80-110 mg/dL
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FPG 70-90 mg/dL
n=121 participants at risk
Aggressive FPG (fasting plasma glucose) titration target range group
|
FPG 80-110 mg/dL
n=122 participants at risk
Conventional FPG (fasting plasma glucose) titration target range group
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/121 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.82%
1/122 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.83%
1/121 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.00%
0/122 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.83%
1/121 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.00%
0/122 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/121 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.82%
1/122 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.83%
1/121 • Number of events 2 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.00%
0/122 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/121 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.82%
1/122 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/121 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.82%
1/122 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.83%
1/121 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.00%
0/122 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.83%
1/121 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.00%
0/122 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
1.7%
2/121 • Number of events 2 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.00%
0/122 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Bone
|
0.83%
1/121 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.00%
0/122 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.83%
1/121 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.00%
0/122 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.83%
1/121 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.00%
0/122 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
Other adverse events
| Measure |
FPG 70-90 mg/dL
n=121 participants at risk
Aggressive FPG (fasting plasma glucose) titration target range group
|
FPG 80-110 mg/dL
n=122 participants at risk
Conventional FPG (fasting plasma glucose) titration target range group
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.83%
1/121 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
2.5%
3/122 • Number of events 3 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
3/121 • Number of events 3 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
2.5%
3/122 • Number of events 3 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
3/121 • Number of events 3 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.82%
1/122 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Infections and infestations
Bronchitis
|
2.5%
3/121 • Number of events 3 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.82%
1/122 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.0%
6/121 • Number of events 6 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
2.5%
3/122 • Number of events 3 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Infections and infestations
Urinary Tract Infection
|
3.3%
4/121 • Number of events 4 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
3.3%
4/122 • Number of events 4 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
3/121 • Number of events 3 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
0.00%
0/122 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.8%
7/121 • Number of events 7 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
1.6%
2/122 • Number of events 2 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/121 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
3.3%
4/122 • Number of events 4 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Dizziness
|
2.5%
3/121 • Number of events 3 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
1.6%
2/122 • Number of events 2 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
5.0%
6/121 • Number of events 6 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
1.6%
2/122 • Number of events 2 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.83%
1/121 • Number of events 1 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
2.5%
3/122 • Number of events 3 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
5/121 • Number of events 5 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
1.6%
2/122 • Number of events 2 • Adverse events were collected in a time span of 20 weeks.
The safety population (safety analysis set) contained all subjects who took at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk maintains the right to be informed of any investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
- Publication restrictions are in place
Restriction type: OTHER