Federal Government. Read our disclaimer for details. Last Update Posted : March 28, Study Description. The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin. Detailed Description:. Drug Information available for: Metformin Metformin hydrochloride Glimepiride.
FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. J Diabetes Investig. With a randomization schedule generated by the Clinical Research Organization eligible patients were linked sequentially to treatment codes allocated at random. Blocked randomization was performed with a block size of 3, 6 with blinded treatment allocation by SAS program. The primary efficacy objective of this study was to compare glycemic control measured by HbA1C among glimepiride, metformin and glimepiride plus metformin with add-on therapy of glargine in type 2 diabetes mellitus receiving nearly maximal combination therapy with metformin plus sulfonylurea for chronic hyperglycemic control.
Samples were taken for HbA1C assessment in screening period and at weeks 4, 8, 16, 24 or at study discontinuation. The study was conducted in accordance with the Declaration of Helsinki and its modifications. The institutional review board of Kangbuk Samsung hospital, Hallym University Sacred Heart Hospital, Kyunghee university medical center, Ilsan Paik Hospital and Hangyang university Guri hospital reviewed and approved the study protocol and all patients gave written informed consent for participation before entry into the trial.
Patients were also required to have a demonstrated ability and willingness to inject insulin and to perform self-monitoring of blood glucose SMBG with use of a plasma-referenced glucose meter. Exclusion criteria included type 1 diabetes; insulin treated type 2 diabetes or having previously received long-term insulin; history of hypersensitivity to the investigational product or to drugs with similar chemical structures; levels of alanine aminotransferase or aspartate aminotransferase greater than twice the upper limit of the normal range; a creatinine level greater than 1.
During the treatment phase, patients had to provide daily self-measured fasting blood glucose values, and episodes of hypoglycemia were recorded in a standardized diary. The investigators checked these values, and the insulin dose was adjusted according to a predefined titration regimen. Insulin glargine was administered as a single daily subcutaneous injection in the morning at a starting dose of 0.
Study medication accountability logs for insulin glargine, glimepiride and metformin were collected and evaluated for assessment of compliance. Safety was assessed in the safety population through adverse events, hypoglycemia, body weight, physical examinations, vital signs, and blood chemistry Physical examinations and vital signs were measured at each visit.
Capillary blood glucose, hypoglycemic episodes, and adverse events were documented by the patient via diary cards or were recorded by the study investigator when mentioned by the patient.
Nocturnal hypoglycemia was defined as hypoglycemia that occurred while the patient was asleep, and before getting up in the morning. Adverse events AEs were also recorded by the investigator. Causality was determined by the investigator and categorized as possibly related or not related to the study medication. Based on the assumption that a common standard deviation is 0. The last observation carried forward LOCF principle was used in patients dropped out before 28 weeks.
In pairwise comparison among 3 groups, a P value of 0. The safety population includes all randomized subjects who received study product. The progression of this study from screening to study endpoint is summarized in Figure 1.
Of the 99 patients randomized, 33 were randomized to the insulin glargine plus metformin group, 34 to the insulin glargine plus glimepirde group and 32 to the insulin glargine plus glimepirde plus metformin group. The baseline characteristics of the study population indicated no significant difference between the groups, both for clinical and laboratory characteristics Table 1. Over the week treatment period, HbA1C levels improved from 8.
Improvement in HbA1c was significantly higher with insulin glargine plus glimepirde plus metformin than with insulin glargine plus metformin 0. The participants measured by HbA1C level less than 6. However, more patients reached an HbA1c level of 7.
Fasting blood glucose levels also improved in all three groups: from 9. AEs were assessed in the Safety population. The number of adverse events during the treatment phase was similar in all three treatment groups insulin glargine plus metformin, 12; insulin glargine plus glimepiride, 16; insulin glargine plus metformin plus glimepiride, There was no report of withdrawals or treatment-emergent adverse events related to the study medication, during the treatment phase.
Serious treatment-emergent adverse events were reported by 5 patients but were not related to the study medications. The risk of hypoglycemia of any type was comparable and the number of patients experiencing episodes of hypoglycemia was similar among all treatment Table 3.
There was no difference in the frequency of clinically noteworthy abnormal laboratory values among the treatment groups data not shown. Weight gain during the treatment period was 1. The lipid profiles and blood pressure also did not significantly differ among the treatment groups data not shown. Initial insulin doses were similar in the three treatment groups. However, the change of the insulin dose from baseline to end point significantly differed among the groups.
Figure 3. The results of this study demonstrated that after weeks of treatment, the combination therapy of metformin and glimepiride plus glargine insulin in patients failing combination therapy with sub-maximal doses of OADs resulted in significant improvement in glycemic control compared with the combination therapy of metformin or sulfonylurea monotherapy plus glargine insulin without differential increase in the risk of weight gain and hypoglycemia and suggest that the addition of insulin glargine to glimepiride and metformin combination therapy in patients with inadequately controlled type 2 diabetes is an effective treatment strategy for achieving glycemic control.
The ADA and EASD guidelines and treatment algorithm for the most appropriate intervention in the management of hyperglycemia for patients with T2DM emphasized that early addition of insulin therapy in patients who do not meet target goals is the most effective of diabetes medications in lowering glycemia [5].
Addition of insulin glargine to glimepiride or metformin monotherapy is one of effective treatment strategies for achieving glycemic control. In this study, after 24 weeks, mean changes from baseline HbA1C was similar between insulin glargine plus metformin and insulin glargine plus glimepirde. Previous controlled trials comparing the combination therapy with oral hypoglycemic agents SU plus Metformin and insulin therapy in patients with poorly controlled type 2 diabetes are sparse [14] — [16] , and among these studies, reports about a peakless, long-acting insulin analog are executive.
Glimepiride Vs. Sandra Wilson Type 2 Diabetes April 6, What is Glimepiride Amaryl? What is Metformin? Similarities and differences between Glimepiride and Metformin Similarities Glimepiride and metformin are oral prescription drugs that are used to control blood sugar in type 2 diabetic patients. Differences Amaryl is available in pill form while Glucophage comes in pill, extended release pill and liquid form.
This article, and other community articles, are not written or reviewed for medical validity by Canadian Insulin or its staff. All views and opinions expressed by the contributing authors are not endorsed by Canadian Insulin. Always consult a medical professional for medical advice, diagnosis, and treatment.
Insulin Side Effects. Written by Sandra Wilson. All rights reserved.
0コメント