Trial Outcomes & Findings for Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™) (NCT NCT01135992)
NCT ID: NCT01135992
Last Updated: 2016-01-22
Results Overview
HbA1C at week 4 and 16
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
143 participants
Primary outcome timeframe
Week 4 and Week 16
Results posted on
2016-01-22
Participant Flow
The trial was conducted at 27 sites in the United States of America (U.S.)
The trial was conducted on subjects with type 2 diabetes mellitus currently treated with IGlar once daily (OD) and oral antidiabetic drug (OAD) therapy.
Participant milestones
| Measure |
IGlar/IDeg
Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \[OAD\] treatment.
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|---|---|
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Overall Study
STARTED
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143
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Overall Study
Exposed
|
142
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Overall Study
Full Analysis Set
|
129
|
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Overall Study
COMPLETED
|
122
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
IGlar/IDeg
Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \[OAD\] treatment.
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
Lack of Efficacy
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1
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Overall Study
Protocol Violation
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2
|
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Overall Study
Withdrawal criteria
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10
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Overall Study
Unclassified
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7
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Baseline Characteristics
Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)
Baseline characteristics by cohort
| Measure |
IGlar/IDeg
n=129 Participants
Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \[OAD\] treatment.
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|---|---|
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Age, Continuous
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58.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
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Sex: Female, Male
Female
|
43 Participants
n=5 Participants
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Sex: Female, Male
Male
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86 Participants
n=5 Participants
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HbA1c (glycosylated haemoglobin) at baseline
|
7.5 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.1 • n=5 Participants
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Fasting plasma glucose (FPG) at baseline
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7.0 mmol/L
STANDARD_DEVIATION 2.2 • n=5 Participants
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Body weight at baseline
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99.3 kg
STANDARD_DEVIATION 20.4 • n=5 Participants
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PRIMARY outcome
Timeframe: Week 4 and Week 16Population: FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment
HbA1C at week 4 and 16
Outcome measures
| Measure |
IGlar/IDeg
n=129 Participants
Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \[OAD\] treatment.
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|---|---|
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HbA1c (Glycosylated Haemoglobin)
Week 4 (N=128) (IGlar)
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7.4 percentage of glycosylated haemoglobin
Standard Deviation 1.0
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HbA1c (Glycosylated Haemoglobin)
Week 16 (N=122)(IDeg)
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7.2 percentage of glycosylated haemoglobin
Standard Deviation 1.1
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SECONDARY outcome
Timeframe: Week 4 and Week 16Population: FAS (Full Analysis Set) includes all subjects that were switched to IDeg 3TW treatment
FPG at week 4 and 16
Outcome measures
| Measure |
IGlar/IDeg
n=129 Participants
Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \[OAD\] treatment.
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|---|---|
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Fasting Plasma Glucose (FPG)
Week 16 (N=122) (IDeg)
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6.3 mmol/L
Standard Deviation 2.2
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Fasting Plasma Glucose (FPG)
Week 4 (N=128) (IGlar)
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7.0 mmol/L
Standard Deviation 2.3
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SECONDARY outcome
Timeframe: Week 0, Week 4, Week 16Population: Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator. Missing data is imputed using LOCF (last observation carried forward)
Change from baseline in body weight after week 4 and after week 16
Outcome measures
| Measure |
IGlar/IDeg
n=142 Participants
Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \[OAD\] treatment.
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|---|---|
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Change in Body Weight
Week 4(N= 142) (IGlar)
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0.1 kg
Standard Deviation 0.4
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Change in Body Weight
Week 16 (N=129) (IDeg)
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0.6 kg
Standard Deviation 2.2
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SECONDARY outcome
Timeframe: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)Population: Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.
Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect
Outcome measures
| Measure |
IGlar/IDeg
n=142 Participants
Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \[OAD\] treatment.
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|---|---|
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Rate of Treatment Emergent Adverse Events (AEs)
Adverse events (N=142)(week 4)(IGlar)
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370 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Serious AEs (N=142 ) (week 4)(IGlar)
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9 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Severe AEs (N=142)(week 4) (IGlar)
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19 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Moderate AEs (N=142) (week 4)(IGlar)
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102 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Mild AEs (N=142)(week 4) (IGlar)
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250 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Fatal AEs (N=142) (week 4) (IGlar)
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0 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Adverse events (N=129) (week 16) (IDeg)
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424 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Serious AEs (n=129) (week 16) (IDeg)
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7 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Severe AEs (N=129) (week 16) (IDeg)
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10 events per 100 patient years
|
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Rate of Treatment Emergent Adverse Events (AEs)
Moderate AEs (N=129) (week 16) (IDeg)
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132 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Mild AEs (N=129) (week 16) (IDeg)
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280 events per 100 patient years
|
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Rate of Treatment Emergent Adverse Events (AEs)
Fatal AEs (N=129) (week 16) (IDeg)
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0 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Adverse Events (N=142) (Total)
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409 events per 100 patient years
|
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Rate of Treatment Emergent Adverse Events (AEs)
Serious AEs (N=142) (Total)
|
8 events per 100 patient years
|
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Rate of Treatment Emergent Adverse Events (AEs)
Severe AEs (N=142) (Total)
|
13 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Moderate AEs (N=142) (Total)
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124 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Mild AEs (N=142) (Total)
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273 events per 100 patient years
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Rate of Treatment Emergent Adverse Events (AEs)
Fatal AEs (N=142)(Total)
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0 events per 100 patient years
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SECONDARY outcome
Timeframe: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)Population: Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator.
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.
Outcome measures
| Measure |
IGlar/IDeg
n=142 Participants
Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \[OAD\] treatment.
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|---|---|
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Rate of Confirmed Hypoglycaemic Episodes
IGlar (N=142) (week 4)
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453 episodes per 100 patient years
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Rate of Confirmed Hypoglycaemic Episodes
IDeg (N=129) (week 16)
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424 episodes per 100 patient years
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SECONDARY outcome
Timeframe: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)Population: Safety Analysis Set includes all subjects who received at least one dose of the investigational product or its comparator
Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.
Outcome measures
| Measure |
IGlar/IDeg
n=142 Participants
Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \[OAD\] treatment.
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|---|---|
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Rate of Nocturnal Confirmed Hypoglycaemic Episodes
IGlar (week 4) (N=142)
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111 episodes per 100 patient years
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Rate of Nocturnal Confirmed Hypoglycaemic Episodes
IDeg (week 16) (N=129)
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83 episodes per 100 patient years
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Adverse Events
IGlar/IDeg
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IGlar/IDeg
n=142 participants at risk
Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug \[OAD\] treatment.
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|---|---|
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Hepatobiliary disorders
Cholelithiasis (IGlar)
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0.00%
0/142 • The adverse events were collected in a time frame of 0-4 weeks (IGlar) and 4-16 weeks (IDeg 3TW)
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Hepatobiliary disorders
Cholelithiaisis (IDeg)
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0.78%
1/129 • Number of events 1 • The adverse events were collected in a time frame of 0-4 weeks (IGlar) and 4-16 weeks (IDeg 3TW)
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
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Hepatobiliary disorders
Cholelithiasis (Total)
|
0.70%
1/142 • Number of events 1 • The adverse events were collected in a time frame of 0-4 weeks (IGlar) and 4-16 weeks (IDeg 3TW)
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
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Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis (IGlar)
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0.70%
1/142 • Number of events 1 • The adverse events were collected in a time frame of 0-4 weeks (IGlar) and 4-16 weeks (IDeg 3TW)
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
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Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis (IDeg)
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0.00%
0/129 • The adverse events were collected in a time frame of 0-4 weeks (IGlar) and 4-16 weeks (IDeg 3TW)
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis (Total)
|
0.70%
1/142 • Number of events 1 • The adverse events were collected in a time frame of 0-4 weeks (IGlar) and 4-16 weeks (IDeg 3TW)
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
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Nervous system disorders
Carotid artery occlusion (IGlar)
|
0.00%
0/142 • The adverse events were collected in a time frame of 0-4 weeks (IGlar) and 4-16 weeks (IDeg 3TW)
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
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Nervous system disorders
Carotid artery occlusion (IDeg)
|
0.78%
1/129 • Number of events 1 • The adverse events were collected in a time frame of 0-4 weeks (IGlar) and 4-16 weeks (IDeg 3TW)
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
|
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Nervous system disorders
Carotid artery occlusion (Total)
|
0.70%
1/142 • Number of events 1 • The adverse events were collected in a time frame of 0-4 weeks (IGlar) and 4-16 weeks (IDeg 3TW)
Safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator
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Other adverse events
Adverse event data not reported
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