New study showed significant reduction in blood glucose with Linagliptin alone and in combination with metformin in adults newly diagnosed with Type 2 Diabetes

Posted: 3 December 2013 | | No comments yet

Boehringer Ingelheim (BI) and Eli Lilly and Company today announced new data1 from a Phase IV study evaluating linagliptin (5 mg) as monotherapy and in combination with metformin (1500 or 2000 mg) in treatment-naive adults with newly diagnosed (<12 months) uncontrolled Type 2 Diabetes (T2D).

The result showed that linagliptin as monotherapy or in initial combination with metformin achieved clinically significant improvements in glucose control in patients with newly diagnosed T2D and marked hyperglycaemia. Results also showed both treatments provided statistically significant reductions in blood glucose levels, with the combination therapy having greater glucose reduction compared to monotherapy. The results were presented during the 2013 World Diabetes Congress, which is being held 2-6 December in Melbourne, Australia.

The study randomised 316 adults with a mean average plasma glucose concentration (HbA1c) of 9.8 percent to receive linagliptin 5 mg once-daily (n = 157) and the initial combination of linagliptin 5 mg once-daily plus metformin twice-daily (uptitrated to a maximal dose of 2000 mg/d; n = 159) for 24 weeks. The results showed:

  • Linagliptin monotherapy and linagliptin + metformin initial combination therapy demonstrated statistically significant reductions in HbA1c of 2.0 percent and 2.8 percent, respectively.
  • HbA1c reduction with the initial combination of linagliptin + metformin was statistically superior to linagliptin alone.
  • A proportion of patients achieved a target HbA1c of <7 percent at week 24 with linagliptin + metformin and linagliptin monotherapy (61 percent and 39 percent, respectively)
  • Both treatments were well tolerated overall with few drug-related or serious adverse events
  • Hypoglycaemia occurred in 3.2 percent and 1.9 percent with linagliptin monotherapy and linagliptin + metformin initial combination therapy, respectively
  • Body weight was stable with linagliptin and decreased in the combination arm (–1.3 kg between group difference)

“Improving glycaemic control in the early stages of Type 2 Diabetes is important, especially in adults with high glucose levels upon initial diagnosis,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The significant drop in HbA1c seen with both linagliptin monotherapy and in initial combination with metformin highlights the importance of these treatment choices for people with T2D.”

The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and several other regulatory authorities worldwide have approved linagliptin for the treatment of adults with T2D as monotherapy or in combination with metformin, metformin + sulphonylurea, and as add-on therapy to insulin. With linagliptin, except as fixed dose combination with metformin, no dose adjustment is required regardless of renal or hepatic function and hence, it can be used at one single dose in a broad range of patients.2,3

About the study

In this international double-blind clinical trial, 316 treatment naïve subjects with recently diagnosed (<12 months) and uncontrolled T2D (baseline HbA1c 8.5 to 12.0 percent) were randomised to receive linagliptin 5 mg once daily (n=157) or the initial combination of linagliptin 5 mg once-daily plus metformin twice-daily (initial dose of 1000 mg/d uptitrated in the first six weeks; maximal dose 2000 mg/d; n=159) for 24 weeks. The primary endpoint was the difference in change from baseline HbA1c between groups in the per-protocol cohort of subjects completing the trial exclusively on study drug (linagliptin, n=113; linagliptin + metformin, n=132). The study did not include a placebo-controlled arm.


  1. S.A.Ross et al. A randomised controlled trial of linagliptin monotherapy vs. initial combination with metformin in newly diagnosed type 2 diabetes patients: Poster No: P-1104. Presented at the World Diabetes Congress, December 2-6, Melbourne
  2. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. Approval 25 September 2011.
  3. Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information. Initial U.S. Approval: 2011