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Second-Line Pharmacotherapy for Type 2 Diabetes — Update [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2013 Jul. (CADTH Optimal Use Report, No. 3.1A.)

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Second-Line Pharmacotherapy for Type 2 Diabetes — Update [Internet].

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APPENDIX 8SUMMARY OF RCTS THAT WERE NOT INCLUDED IN THE NMA

Study IDComparators
(Added-on to Metformin)
DescriptionSummary of Key Results
Glycemic ControlBody WeightHypoglycemia
EUREXA43
  • 48 months
  • Open-label
  • N = 1029
Glycemic failurea
Fewer exenatide-treated patients had treatment failure (41% vs. 54%; P = 0.002), RD = 12.4 (6.2 to 18.6), HR = 0.748 (0.623 to 0.899)
A1C < 7% and < 6.5%
More exenatide-treated patients had A1C < 7% (44% vs. 31%; P < 0.0001)
Mean weight change favoured exenatide compared with glimepiride
(−3.32 kg vs. 1.15 kg; P < 0.0001)
Significantly fewer patients in the exenatide group reported hypoglycemia (P < 0.0001)
Cho et al. 201099
  • Mitiglinide (10 mg t.i.d.)
  • Placebo
  • 16 weeks
  • Double-blind
  • N = 145
Mean change in A1C was greater with mitiglinide compared with placebo (−0.7% vs. −0.4%; P = 0.002)No difference between mitiglinide and placebo (−0.1 vs. −0.5 kg; P = 0.218)One episode with mitiglinide and none with placebo
Derosa et al. 2012149
  • 12 months
  • Double-blind
  • N = 174
Mean decrease in A1C favoured exenatide over placebo (−1.2% vs. −0.4%; P < 0.05)Mean weight change favoured exenatide over placebo (−6.4 kg vs. −2.3 kg; P < 0.01)Not reported
Wang et al. 2011155
  • 24 weeks
  • Open-label
  • N = 55
A1C was significantly reduced with acarbose (−0.7%; P < 0.001) and glyburide (−1.2%; P < 0.001)Mean weight decreased significantly with acarbose (−1.5 kg; P < 0.002). Not reported for glyburideHypoglycemia was more common with glyburide compared with acarbose (23.1% vs. 0%)
Ahren et al. 2004100
  • Vildagliptin (50 mg q.d.)
  • Placebo
  • 12 weeks
  • Double-blind
  • N = 107
A1C was significantly reduced with vildagliptin compared with placebo (MD = −0.7% [SE: 0.1]; P < 0.001)No difference in change in body weight between vildagliptin and placebo groups (−0.2 kg in both)2 patients in the vildagliptin group experience an episode of hypoglycemia
Schernthaner et al. 200449
  • Gliclazide MR (30–120 mg/day)
  • Glimepiride (1–6 mg/day)
  • 7 months
  • Double-blind
  • N = 219
No significant difference between the groupsNo significant difference between the groupsHypoglycemia was less common with gliclazide compared with glimepiride (3.7% vs. 8.9%; P = 0.003)
Von Bibra et al. 200836
  • 4 months
  • Open-label
  • N = 13
No significant difference between the groupsNot reportedOne patient in the glimepiride group reported hypoglycemia
Khanolkar et al. 200846
  • 6 months
  • Open-label
  • N = 50
No significant difference between the groupsNot reportedNot reported

b.i.d. = twice daily; HR = hazard ratio; MD = mean difference; MTD = maximum tolerated dose; NMA = network meta-analysis; RCT = randomized controlled trial; RD = risk difference; t.i.d. = three times daily; vs. = versus.

a

The primary outcome of the EUREXA trial was time to inadequate glycemic control and need for alternative treatment (defined as an A1C of more than 9% after the first 3 months of treatment, or more than 7% at two consecutive visits after the first 6 months).

Copyright © CADTH 2013.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial- NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK169672

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