PMID- 27098525
OWN - NLM
STAT- MEDLINE
DCOM- 20170501
LR  - 20221207
IS  - 1179-6901 (Electronic)
IS  - 1174-5886 (Print)
IS  - 1174-5886 (Linking)
VI  - 16
IP  - 2
DP  - 2016 Jun
TI  - A Multinational, Randomized, Open-label, Treat-to-Target Trial Comparing Insulin 
      Degludec and Insulin Glargine in Insulin-Naive Patients with Type 2 Diabetes 
      Mellitus.
PG  - 239-49
LID - 10.1007/s40268-016-0134-z [doi]
AB  - INTRODUCTION: To lower the barrier for initiating insulin treatment and obtain 
      adequate glycemic control in type 2 diabetes mellitus (T2DM), new basal insulin 
      preparations with improved pharmacological properties and consequently a lower 
      risk of hypoglycemia are needed. The objective of this trial was to confirm the 
      efficacy and compare the safety of insulin degludec (IDeg) with insulin glargine 
      (IGlar) in a multinational setting with two thirds of subjects enrolled in China. 
      METHODS: This was a 26-week, randomized, open-label, parallel-group, 
      treat-to-target, non-inferiority trial in 833 subjects with T2DM (48 % were 
      female, mean age 56 years, diabetes duration 8 years), inadequately controlled on 
      oral antidiabetic drugs (OADs). Subjects were randomized 2:1 to once-daily IDeg 
      (555 subjects) or IGlar (278 subjects), both with metformin. The primary endpoint 
      was the change from baseline in glycosylated hemoglobin (HbA1c) after 26 weeks. 
      RESULTS: The completion rate was high (IDeg 94.2 %; IGlar 91.4 %). Mean HbA1c 
      decreased from 8.3 to 7.0 % in both groups. Estimated treatment difference (ETD) 
      [95 % confidence interval (CI)] IDeg-IGlar in change from baseline was -0.05 % 
      points [-0.18 to 0.08], confirming the non-inferiority of IDeg to IGlar. The 
      proportion of subjects achieving HbA1c <7.0 % was 54.2 and 51.4 % with IDeg and 
      IGlar, respectively (estimated odds ratio [95 % CI] IDeg/IGlar: 1.14 [0.84 to 
      1.54]). The mean decrease in fasting plasma glucose, self-measured plasma glucose 
      profiles, and insulin dose were similar between groups. Numerically lower rates 
      of overall (estimated rate ratio [95 % CI] IDeg/IGlar: 0.80 [0.59 to 1.10]) and 
      nocturnal (0.77 [0.43 to 1.37]) confirmed hypoglycemia were observed with IDeg 
      compared with IGlar. No treatment differences in other safety parameters were 
      found. Subjects were more satisfied with the IDeg device compared with the IGlar 
      device as reflected by the total Treatment Related Impact Measures-Diabetes 
      Device score (ETD [95 % CI] IDeg-IGlar: 2.2 [0.2 to 4.3]). CONCLUSION: IDeg 
      provided adequate glycemic control non-inferior to IGlar and a tendency for a 
      lower hypoglycemia rate. IDeg is considered suitable for initiating insulin 
      therapy in T2DM patients on OADs requiring intensified treatment. TRIAL 
      REGISTRATION: Clinicaltrials.gov NCT01849289.
FAU - Pan, Changyu
AU  - Pan C
AD  - Department of Endocrinology, PLA General Hospital, No. 28 Fu Xing Road, Beijing, 
      100853, China. panchy301@126.com.
FAU - Gross, Jorge L
AU  - Gross JL
AD  - Centro de Pesquisas em Diabetes, Porto Alegre, Brazil.
FAU - Yang, Wenying
AU  - Yang W
AD  - Department of Endocrinology, China-Japan Friendship Hospital, Beijing, China.
FAU - Lv, Xiaofeng
AU  - Lv X
AD  - Department of Endocrinology, PLA Military General Hospital of Beijing, Beijing, 
      China.
FAU - Sun, Li
AU  - Sun L
AD  - Siping Central People's Hospital, Siping, China.
FAU - Hansen, Charlotte Thim
AU  - Hansen CT
AD  - Novo Nordisk, Soborg, Denmark.
FAU - Xu, Hongfei
AU  - Xu H
AD  - Novo Nordisk China Pharmaceuticals, Beijing, China.
FAU - Wagner, Robert
AU  - Wagner R
AD  - Community Research, Crestview Hills, KY, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT01849289
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - New Zealand
TA  - Drugs R D
JT  - Drugs in R&D
JID - 100883647
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Insulin, Long-Acting)
RN  - 2ZM8CX04RZ (Insulin Glargine)
RN  - 54Q18076QB (insulin degludec)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Blood Glucose/drug effects
MH  - China
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Female
MH  - Glycated Hemoglobin/drug effects
MH  - Humans
MH  - Hypoglycemia/physiopathology
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/blood/*therapeutic 
      use
MH  - Insulin
MH  - Insulin Glargine/administration & dosage/adverse effects/blood/*therapeutic use
MH  - Insulin, Long-Acting/administration & dosage/adverse effects/blood/*therapeutic 
      use
MH  - Male
MH  - Metformin/therapeutic use
MH  - Middle Aged
MH  - Treatment Outcome
PMC - PMC4875929
EDAT- 2016/04/22 06:00
MHDA- 2017/05/02 06:00
PMCR- 2016/04/20
CRDT- 2016/04/22 06:00
PHST- 2016/04/22 06:00 [entrez]
PHST- 2016/04/22 06:00 [pubmed]
PHST- 2017/05/02 06:00 [medline]
PHST- 2016/04/20 00:00 [pmc-release]
AID - 10.1007/s40268-016-0134-z [pii]
AID - 134 [pii]
AID - 10.1007/s40268-016-0134-z [doi]
PST - ppublish
SO  - Drugs R D. 2016 Jun;16(2):239-49. doi: 10.1007/s40268-016-0134-z.