Boehringer Ingelheim Unveils Diabetes Pipeline
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“Type 2 diabetes is a growing public health concern,” said
Results from the Phase II study presented at
“Many patients don’t achieve adequate blood sugar control with commonly used diabetes medications like metformin. The significant reduction in HbA1c levels seen in this trial is encouraging as it indicates linagliptin may have a potential role in the management of this prevalent disease,” said Dr. Thor Voigt, senior vice president, Medicine and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Type 2 diabetes is a progressive chronic condition that frequently requires long-term treatment. A range of treatment options and combination regimens are needed so physicians can tailor therapy to the individual patient needs. We are now awaiting results from additional ongoing studies which will further assess the full potential of linagliptin for the treatment of type 2 diabetes.”
DPP-4 inhibitors are a newer class of oral hypoglycemics that target the incretin hormones GLP-1 and GIP, which are believed to be involved with regulating blood sugar.(2)
Linagliptin is a compound discovered by Boehringer Ingelheim and is being developed as an oral once-daily tablet for the treatment of type 2 diabetes. The compound is currently being studied in five pivotal Phase III clinical trials including more than 4,000 patients. These trials are fully recruited and underway globally and in many states across the U.S.(3)
Boehringer Ingelheim is also investigating sodium-dependent glucose co-transporter-2 inhibitors (SGLT-2 inhibitors), which are a new, emerging class of antidiabetic compounds that block tubular reabsorption of glucose in the kidney.(4) Phase IIb clinical trials for this innovative approach to diabetes treatment are underway. There are currently no SGLT-2 inhibitors approved by the U.S. Food and Drug Administration (FDA).
About the linagliptin (BI 1356) Phase II study
The aim of the 12-week, international, randomized, double-blind placebo-controlled study was to assess the efficacy and safety profile of linagliptin as add-on therapy in patients with type 2 diabetes who were failing to achieve glycemic control despite being treated with metformin.(1) The primary endpoint was the change in HbA1c from baseline to week 12.(1) Out of the 333 randomized patients, 268 patients received double-blind treatment with linagliptin (1 mg, n=65; 5 mg, n=66; 10 mg, n=66) or placebo.(1) An open-label arm with 65 patients on glimepiride was added for descriptive control.(1)
Additional results from the study
The addition of linagliptin to metformin treatment for 12 weeks resulted in clinically relevant and statistically significant reductions in HbA1c and fasting blood sugar or fasting plasma glucose (FPG) levels (p-values of less than 0.05%):(1)
- Statistically significant reductions in mean HbA1c levels with linagliptin 5 mg and 10 mg compared with metformin alone (both p<0.001) were observed from week four though week 12.(1)
- In addition, all linagliptin doses showed significant reductions in FPG levels compared with metformin alone (placebo-corrected mean changes from baseline; -19.2 mg/dL for 1 mg, -34.7 mg/dL for 5 mg, and -29.0 mg/dL for 10 mg).(1)
- In the open-label comparator arm, the placebo-corrected mean change from baseline in HbA1c was -0.90 percent.(1)
- More than 85% of the patients receiving the 5mg and 10mg doses of linagliptin demonstrated greater that or equal to 80% DPP-4 inhibition at trough at week 12(1)
- HbA1c reductions of at least 0.5 percent were achieved in 44 percent to 53 percent of patients on linagliptin, but only in 13 percent of the patients receiving metformin alone.(1)
About type 2 diabetes
There are approximately 23.6(5) million Americans and 246 million people worldwide(6) with diabetes. Type 2 diabetes is the most common type of diabetes accounting for more than 90% of all diabetes cases in the developed world.(7) Every ten seconds two people develop diabetes and one person dies from diabetes-related causes around the world.(6) Each year, more than 200,000 people in
To address this unmet need, Boehringer Ingelheim is committed to researching and developing new compounds in this therapeutic area.
Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim,
In 2008, Boehringer Ingelheim posted net sales of US
For more information, please visit http://us.boehringer-ingelheim.com.
(1) DPP-4 inhibitor linagliptin improves glycaemic control in type 2 diabetes patients when added to onogoing metformin therapy.
(2) Nathan DM et al. Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy. Diabetes Care 21:1-11, 2008.
(3) Clinicaltrials.gov. Available at: http://www.clinicaltrials.gov/ct2/results?term=BI+1356. Accessed on:
(4) Jabbour SA, et al. Sodium glucose co-transporter 2 inhibitors: blocking renal tubular reabsorption of glucose to improve glycaemic control in patients with diabetes. International Journal of Clinical Practice,
(5) American Diabetes Association. 2007 National Diabetes Fact Sheet.
(6) International Diabetes Federation. Diabetes Atlas. 3rd edn.
(7) World Health Organization. Fact Sheet No. 312: What is Diabetes? Available at:
http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed on:
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.