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CompletedNCT00611884Updated Mar 3, 2017Results posted

Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

A Phase 2 interventional study of insulin glargine and insulin degludec in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 29 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-03-03.

Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
245
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 245 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
  • Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximeum 14 days within the last 3 months)
  • Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea (SU) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to the summary of product characteristics (SPC) or locally approved PI
  • HbA1c 7.0-11.0 % (both inclusive)
  • Body Mass Index (BMI) 23-42 kg/m\^2 [lb/in\^2 x 703] (both inclusive)

Exclusion criteria

Exclusion Criteria:

  • Metformin contraindication according to local practice
  • Thiazolidinedione (TZD) treatment within previous three months prior to visit 1
  • Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation
  • Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial drug
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
245 participants (actual)

Study arms

  • Experimental
    SIBA (D)

    Drug: insulin degludec · Drug: metformin

  • Experimental
    SIBA (E)

    Drug: insulin degludec · Drug: metformin

  • Experimental
    SIBA (D) M, W, F

    Drug: insulin degludec · Drug: metformin

  • Active comparator
    IGlar

    Drug: insulin glargine · Drug: metformin

Interventions

  • Druginsulin glargine

    Treat-to-target dose titration scheme, s.c. injection.

  • Druginsulin degludec

    Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily

  • Druginsulin degludec

    Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily

  • Druginsulin degludec

    Formulation D: Treat-to-target dose titration scheme, s.c. injection, 3 times weekly

  • Drugmetformin

    Tablets, 1500-2000 mg/day

06

What researchers measure

Primary outcomes

  1. Change in Glycosylated Haemoglobin (HbA1c)

    Change from baseline in HbA1c after 16 weeks of treatment

    Time frame: Week 0, Week 16

Secondary outcomes

  1. Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)

    Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.

    Time frame: Week 16

  2. Rate of Major and Minor Hypoglycaemic Episodes

    Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.

    Time frame: Week 0 to Week 16 + 5 days follow up

  3. Rate of Nocturnal Major and Minor Hypoglycaemic Episodes

    Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).

    Time frame: Week 0 to Week 16 + 5 days follow up

  4. Rate of Treatment Emergent Adverse Events (AEs)

    Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: 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.

    Time frame: Week 0 to Week 16 + 5 days follow up

  5. Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)

    Mean values at Week -4 and at Week 16

    Time frame: Week -4, Week 16

  6. Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)

    Mean values at Week -4 and at Week 16

    Time frame: Week -4, Week 16

  7. Laboratory Safety Parameters (Biochemistry): Serum Creatinine

    Mean values at Week -4 and at Week 16

    Time frame: Week -4, Week 16

  8. Vital Signs: Diastolic Blood Pressure (BP)

    Mean values at baseline (Week 0) and at Week 16

    Time frame: Week 0, Week 16

  9. Vital Signs: Systolic Blood Pressure (BP)

    Mean values at baseline (Week 0) and at Week 16

    Time frame: Week 0, Week 16

  10. Vital Signs: Pulse

    Mean values at baseline (Week 0) and at Week 16

    Time frame: Week 0, Week 16

  11. Physical Examination

    Physical examination was performed at screening (Week -4), randomisation (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.

    Time frame: Week -4, Week 0, Week 8, Week 16

07

Results

Posted Nov 16, 2015

Participant flow

There were 28 sites: Canada (4), India (4), South Africa (3) and the United States of America (17).

Participant flow — Overall Study
MilestoneSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
Started61606262
Exposed58596161
Completed52515856
Not completed9946
Withdrew: Adverse event1001
Withdrew: Non-compliance1422
Withdrew: Lack of efficacy0100
Withdrew: Unclassified7423

Outcome measures

PrimaryChange in Glycosylated Haemoglobin (HbA1c)

Change from baseline in HbA1c after 16 weeks of treatment

Time frame:
Week 0, Week 16
Reported as:
Mean · percentage of glycosylated haemoglobin
Change in Glycosylated Haemoglobin (HbA1c)
percentage of glycosylated haemoglobinSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
Change in Glycosylated Haemoglobin (HbA1c)-1.26 ± 1.11-1.28 ± 1.11-1.46 ± 1.06-1.49 ± 1.12
SecondaryMean of 9-point Self Measured Plasma Glucose Profile (SMPG)

Mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast.

Time frame:
Week 16
Reported as:
Least squares mean · mmol/L
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
mmol/LSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)8.30 ± 0.428.55 ± 0.428.45 ± 0.428.42 ± 0.41
SecondaryRate of Major and Minor Hypoglycaemic Episodes

Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.

Time frame:
Week 0 to Week 16 + 5 days follow up
Reported as:
Number · Episodes/100 years of patient exposure
Rate of Major and Minor Hypoglycaemic Episodes
Episodes/100 years of patient exposureSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
Major0060
Minor8960221113
SecondaryRate of Nocturnal Major and Minor Hypoglycaemic Episodes

Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included).

Time frame:
Week 0 to Week 16 + 5 days follow up
Reported as:
Number · Episodes/100 years of patient exposure
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Episodes/100 years of patient exposureSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
Major0060
Minor612170
SecondaryRate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: 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.

Time frame:
Week 0 to Week 16 + 5 days follow up
Reported as:
Number · Events/100 years of patient exposure
Rate of Treatment Emergent Adverse Events (AEs)
Events/100 years of patient exposureSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
Adverse events (AEs)594430488622
Serious AEs6050
Severe AEs126028
Moderate AEs114102110141
Mild AEs468323379452
Fatal0000
SecondaryLaboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)

Mean values at Week -4 and at Week 16

Time frame:
Week -4, Week 16
Reported as:
Mean · IU/L
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
IU/LSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
ALAT, Week -4, N=56, 59, 62, 6034.6 ± 19.929.2 ± 16.330.9 ± 16.032.9 ± 22.0
ALAT, Week 16, N=53, 53, 58, 5625.7 ± 13.124.7 ± 14.424.3 ± 13.030.0 ± 25.3
SecondaryLaboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)

Mean values at Week -4 and at Week 16

Time frame:
Week -4, Week 16
Reported as:
Mean · IU/L
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
IU/LSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
ASAT, Week -4, N=56, 59, 62, 6026.7 ± 13.622.5 ± 9.923.9 ± 8.524.2 ± 12.6
ASAT, Week 16, N=53, 53, 58, 5623.3 ± 10.021.8 ± 7.721.7 ± 7.724.1 ± 13.7
SecondaryLaboratory Safety Parameters (Biochemistry): Serum Creatinine

Mean values at Week -4 and at Week 16

Time frame:
Week -4, Week 16
Reported as:
Mean · umol/L
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
umol/LSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
Creatinine, Week -4, N=56, 59, 62, 6074.5 ± 15.275.4 ± 19.073.2 ± 16.172.4 ± 13.9
Creatinine, Week 16, N=53, 53, 58, 5676.1 ± 15.976.6 ± 19.171.5 ± 15.674.2 ± 14.4
SecondaryVital Signs: Diastolic Blood Pressure (BP)

Mean values at baseline (Week 0) and at Week 16

Time frame:
Week 0, Week 16
Reported as:
Mean · mmHg
Vital Signs: Diastolic Blood Pressure (BP)
mmHgSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
Week 0 (Baseline), N=57, 59, 62, 6181 ± 982 ± 980 ± 879 ± 7
Week 16, N=55, 55, 60, 5679 ± 882 ± 878 ± 977 ± 8
SecondaryVital Signs: Systolic Blood Pressure (BP)

Mean values at baseline (Week 0) and at Week 16

Time frame:
Week 0, Week 16
Reported as:
Mean · mmHg
Vital Signs: Systolic Blood Pressure (BP)
mmHgSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
Week 0 (Baseline), N=57, 59, 62, 61129 ± 14131 ± 13129 ± 15127 ± 14
Week 16, N=55, 55, 60, 56126 ± 14131 ± 15126 ± 16128 ± 13
SecondaryVital Signs: Pulse

Mean values at baseline (Week 0) and at Week 16

Time frame:
Week 0, Week 16
Reported as:
Mean · beats/minute
Vital Signs: Pulse
beats/minuteSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
Week 0 (Baseline), N=57, 59, 62, 6179 ± 1079 ± 979 ± 976 ± 9
Week 16, N=55, 55, 60, 5677 ± 1178 ± 1079 ± 974 ± 9
SecondaryPhysical Examination

Physical examination was performed at screening (Week -4), randomisation (Week 0) and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.

Time frame:
Week -4, Week 0, Week 8, Week 16

No measurements were reported for this outcome.

Adverse events

Collected over The adverse events were collected in a time frame of 16 weeks + 5 days follow up. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SIBA (D)—1/57 (1.8%)22/57 (38.6%)
SIBA (E)—0/59 (0%)16/59 (27.1%)
SIBA (D) M, W, F—1/62 (1.6%)19/62 (30.6%)
IGlar—0/61 (0%)23/61 (37.7%)
Most frequent serious events
Most frequent serious events
EventSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
Atrial fibrillationCardiac disorders1/570/590/620/61
Coronary artery diseaseCardiac disorders0/570/591/620/61
Most frequent other events
Showing 10 of 13
Most frequent other events
EventSIBA (D)SIBA (E)SIBA (D) M, W, FIGlar
HeadacheNervous system disorders3/572/595/628/61
NasopharyngitisInfections and infestations2/572/594/627/61
DiarrhoeaGastrointestinal disorders3/573/593/626/61
CoughRespiratory, thoracic and mediastinal disorders1/572/591/625/61
Back painMusculoskeletal and connective tissue disorders4/570/595/623/61
InfluenzaInfections and infestations1/574/590/621/61
ToothacheGastrointestinal disorders3/570/592/621/61
DyslipidaemiaMetabolism and nutrition disorders3/571/590/620/61
Pain in extremityMusculoskeletal and connective tissue disorders3/572/592/623/61
HypertensionVascular disorders3/571/590/621/61

Baseline characteristics

Age, Continuous
Age, Continuous(years)SIBA (D)SIBA (E)SIBA (D) M, W, FIGlarTotal
Mean53.9 ± 8.555.3 ± 8.754.4 ± 8.853.1 ± 10.254.2 ± 9.1
Sex: Female, Male
Sex: Female, Male(Participants)SIBA (D)SIBA (E)SIBA (D) M, W, FIGlarTotal
Female22273425108
Male39332837137
Glycosylated haemoglobin (HbA1c)
Glycosylated haemoglobin (HbA1c)(percentage of glycosylated haemoglobin)SIBA (D)SIBA (E)SIBA (D) M, W, FIGlarTotal
Mean8.7 ± 1.18.6 ± 1.28.8 ± 1.18.7 ± 1.18.7 ± 1.1
Fasting plasma glucose (FPG)
Fasting plasma glucose (FPG)(mmol/L)SIBA (D)SIBA (E)SIBA (D) M, W, FIGlarTotal
Mean10.6 ± 3.69.9 ± 3.210.6 ± 3.49.8 ± 3.110.2 ± 3.4
08

Study locations

29 sites
  • Novo Nordisk Investigational Site
    Inglewood, California 90301, United States
  • Novo Nordisk Investigational Site
    Los Angeles, California 90057, United States
  • Novo Nordisk Investigational Site
    Redlands, California 92374, United States
  • Novo Nordisk Investigational Site
    Spring Valley, California 91978, United States
  • Novo Nordisk Investigational Site
    Jacksonville, Florida 32204, United States
  • Novo Nordisk Investigational Site
    Idaho Falls, Idaho 83404-7596, United States
  • Novo Nordisk Investigational Site
    Chicago, Illinois 60607, United States
  • Novo Nordisk Investigational Site
    Chicago, Illinois 60616, United States
  • Novo Nordisk Investigational Site
    Springfield, Illinois 62711, United States
  • Novo Nordisk Investigational Site
    Greensboro, North Carolina 27408, United States
  • Novo Nordisk Investigational Site
    Medford, Oregon 97504, United States
  • Novo Nordisk Investigational Site
    Simpsonville, South Carolina 29681, United States
  • Novo Nordisk Investigational Site
    Kingsport, Tennessee 37660, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75230, United States
  • Novo Nordisk Investigational Site
    San Antonio, Texas 78229, United States
  • Novo Nordisk Investigational Site
    Newport News, Virginia 23606, United States
  • Novo Nordisk Investigational Site
    Renton, Washington 98057, United States
  • Novo Nordisk Investigational Site
    Milwaukee, Wisconsin 53209, United States
  • Novo Nordisk Investigational Site
    Cambridge, Ontario N1R 7L6, Canada
  • Novo Nordisk Investigational Site
    Etobicoke, Ontario M9R 4E1, Canada
  • Novo Nordisk Investigational Site
    Toronto, Ontario M5C 2T2, Canada
  • Novo Nordisk Investigational Site
    Toronto, Ontario M5T 3L9, Canada
  • Novo Nordisk Investigational Site
    Hyderabad, Andhra Pradesh 500082, India
  • Novo Nordisk Investigational Site
    Kochi, Kerala 682041, India
  • Novo Nordisk Investigational Site
    Mumbai, Maharashtra 400012, India
  • Novo Nordisk Investigational Site
    Vellore, Tamil Nadu 632004, India
  • Novo Nordisk Investigational Site
    Johannesburg, Gauteng 2001, South Africa
  • Novo Nordisk Investigational Site
    Durban, KwaZulu-Natal 4001, South Africa
  • Novo Nordisk Investigational Site
    Durban, KwaZulu-Natal 4126, South Africa
09

References and documents

Publications

  • Zinman B, Fulcher G, Rao PV, Thomas N, Endahl LA, Johansen T, Lindh R, Lewin A, Rosenstock J, Pinget M, Mathieu C. Insulin degludec, an ultra-long-acting basal insulin, once a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: a 16-week, randomised, open-label, phase 2 trial. Lancet. 2011 Mar 12;377(9769):924-31. doi: 10.1016/S0140-6736(10)62305-7. PubMed 21396703 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00611884
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 11, 2008
Start date
Jan 2008
Primary completion
Aug 2008
Completion
Aug 2008
Results posted
Nov 16, 2015
Last update
Mar 3, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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