PMID- 23672632
OWN - NLM
STAT- MEDLINE
DCOM- 20140210
LR  - 20220310
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 29
IP  - 8
DP  - 2013 Aug
TI  - Efficacy and safety of linagliptin added to metformin and sulphonylurea in 
      Chinese patients with type 2 diabetes: a sub-analysis of data from a randomised 
      clinical trial.
PG  - 921-9
LID - 10.1185/03007995.2013.805123 [doi]
AB  - OBJECTIVES: To evaluate the efficacy and safety of linagliptin in Chinese 
      patients with type 2 diabetes mellitus (T2DM) inadequately controlled by 
      metformin and sulphonylurea. RESEARCH DESIGN AND METHODS: Data for a pre-defined 
      Chinese subgroup who participated in a Phase III randomised, placebo-controlled, 
      24 week trial (NCT00602472) were analysed. The primary endpoint was change in 
      HbA1c from baseline to 24 weeks. Apart from safety endpoints, secondary endpoints 
      included changes in FPG and measures of insulin secretion and resistance. 
      RESULTS: A total of 192 Chinese patients with T2DM participated in the 
      pre-defined analysis; 144 and 48 patients received linagliptin or placebo, 
      respectively, added to metformin and sulphonylurea. Baseline characteristics 
      (mean [+/-SD]) for linagliptin and placebo were similar: HbA1c: 8.1% (+/-0.85) and 
      8.1% (+/-0.84); body mass index: 25.9 (+/-3.2) and 25.6 (+/-3.4) kg/m(2), respectively. 
      Placebo-corrected mean (+/-SE) change in HbA1c from baseline at 24 weeks was -0.68% 
      (0.14) with linagliptin-based treatment (95% CI: -0.96 to -0.39; P<0.0001). 
      Placebo-corrected mean (+/-SE) change in FPG from baseline at 24 weeks with 
      linagliptin was -18.8 (6.5) mg/dL (-1.0 [0.4] mmol/L; 95% CI: -31.7 to -5.9; 
      P=0.0044). Overall adverse event (AE) rates with linagliptin and placebo 
      including background medication were similar (38.9% and 43.8%, respectively). 
      Drug-related AEs were reported by 12.5% and 2.1% of linagliptin and placebo 
      patients, respectively. Differences were due to hypoglycaemia (10.4% and 0.0%, 
      respectively). No severe hypoglycaemia was reported in either group of this 
      sub-population. CONCLUSION: Linagliptin in combination with metformin and 
      sulphonylurea has a favourable safety profile and is an efficacious and well 
      tolerated treatment option for Chinese patients with inadequately controlled 
      T2DM. Reduction of sulphonylurea dose should be considered to minimise risk of 
      hypoglycaemia. Although the findings of this pre-specified sub-analysis may be 
      limited by the number of patients in the subgroup, the results were generally 
      consistent with those for the overall population. CLINICALTRIALS IDENTIFIER: 
      NCT00602472.
FAU - Zeng, Zhengpei
AU  - Zeng Z
AD  - Peking Union Medical College Hospital, Beijing, China.
FAU - Yang, Jin-Kui
AU  - Yang JK
FAU - Tong, Nanwei
AU  - Tong N
FAU - Yan, Shengli
AU  - Yan S
FAU - Zhang, Xiling
AU  - Zhang X
FAU - Gong, Yan
AU  - Gong Y
FAU - Woerle, Hans-Juergen
AU  - Woerle HJ
LA  - eng
SI  - ClinicalTrials.gov/NCT00602472
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20130604
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Placebos)
RN  - 0 (Purines)
RN  - 0 (Quinazolines)
RN  - 0 (Sulfonylurea Compounds)
RN  - 3X29ZEJ4R2 (Linagliptin)
RN  - 9100L32L2N (Metformin)
SB  - IM
MH  - Aged
MH  - China
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Linagliptin
MH  - Male
MH  - Metformin/administration & dosage/*therapeutic use
MH  - Middle Aged
MH  - Placebos
MH  - Purines/administration & dosage/adverse effects/*therapeutic use
MH  - Quinazolines/administration & dosage/adverse effects/*therapeutic use
MH  - Sulfonylurea Compounds/administration & dosage/*therapeutic use
EDAT- 2013/05/16 06:00
MHDA- 2014/02/11 06:00
CRDT- 2013/05/16 06:00
PHST- 2013/05/16 06:00 [entrez]
PHST- 2013/05/16 06:00 [pubmed]
PHST- 2014/02/11 06:00 [medline]
AID - 10.1185/03007995.2013.805123 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2013 Aug;29(8):921-9. doi: 10.1185/03007995.2013.805123. Epub 
      2013 Jun 4.