The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial

Abstract

BackgroundMetformin plays an important role in diabetes treatment. Studies have shown that the combined use of oral hypoglycemic medications is more effective than metformin monotherapy. In this double-blind, randomized, placebo-controlled, multicenter trial, we evaluated whether Jinlida, a Chinese herbal medicine, enhances the glycemic control of metformin in type 2 diabetes patients whose HbA1c was ineffectively controlled with metformin alone.MethodsA total of 186 diabetes patients were enrolled in this double-Blind, randomized, placebo-controlled, multicenter trial. Subjects were randomly allocated to receive either Jinlida (9 g) or the placebo TID for 12 consecutive weeks. All subjects in both groups also continuously received their metformin without any dose change. During this 12-week period, the HbA1c, FPG, 2h PG, body weight, BMI were assessed. HOMA insulin resistance (HOMA-IR) and β-cell function (HOMA- β) were also evaluated.ResultsAt week 12, compared to the HbA1c level from week 0, the level of the Jinlida group was reduced by 0.92 ± 1.09% and that of the placebo group was reduced by 0.53 ± 0.94%. The 95% CI was 0.69 - 1.14 for the Jinlida group vs. 0.34 - 0.72 for the placebo group. There was a very significant HbA1c reduction between the two groups after 12 weeks (p < 0.01). Both FG and 2h PG levels of the Jinlida group and placebo group were reduced from week 0. There were a very significant FG and 2h PG level reductions between the two groups after 12 weeks (both p < 0.01). The Jinlida group also showed improved β-cell function with a HOMA-β increase (p < 0.05). No statistical significance was observed in the body weight and BMI changes. No serious adverse events were reported.ConclusionJinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone. This Chinese herbal medicine may have a clinical value as an add-on medication to metformin monotherapy.Trial RegistrationChinese Clinical Trial Register ChiCTR-TRC-13003159

Evaluation of the Chinese herbal medicine Jinlida in type 2 diabetes patients based on stratification: Results of subgroup analysis from a 12‐week trial

“…Patients with complications from diabetes, serious renal, hepatic, and heart problems, mental illness, and women of child‐bearing age who were not using adequate birth control methods were excluded from the study. Patients who had used a weight‐control medication in the previous 3 months or had taken any oral antidiabetic drug or insulin in addition to metformin were also excluded from the study …”

“…All subjects in both groups also continued with their metformin without any change in dose. The chemical composition of Jinlida was determined by ultra‐performance liquid chromatography–mass spectrometry and has been described in detail elsewhere …”

“…The HbA1c levels were measured in a central laboratory (Guang'anmen Hospital, China Academy of Chinese Medical Sciences; ADAMSTMA1c HA‐8160; ARKRAY, Kyoto, Japan). The secondary efficacy parameters were mean changes at Week 12 in insulin resistance and β‐cell function . Estimates of insulin resistance and β‐cell function were made using FPG and immunoreactive insulin applied to the homeostatic model assessment (HOMA) …”

“…In that trial, 192 adult T2DM patients took Jinlida (9 g) or placebo for 12 consecutive weeks. Both glycemia and HbA1c were reduced more significantly in the Jinlida group compared with placebo ( P < 0.01) . In addition, β‐cell function improved in the Jinlida group, with an increase in homeostatic model assessment of β‐cell function (HOMA‐β; P < 0.05).…”

“…Jinlida, taken as an add‐on Chinese patent medicine and containing Ginseng, Rhizoma Polygonati, Rhizome of Swordlike Atractylodes, Fortune Eupatorium Herb, Radix sophorae flavescentis, Ophiopogon japonicas, Pueraria, Coptis chinensis, Epimedium and Salvia miltiorrhiza, can significantly lower HbA1c, fasting plasma glucose (FPG), and 2‐h postprandial glucose (2hPG) levels in patients with T2DM . We undertook a multicenter double‐blind randomized placebo‐controlled clinical trial to evaluate the efficacy and safety of Jinlida in DM patients . In that trial, 192 adult T2DM patients took Jinlida (9 g) or placebo for 12 consecutive weeks.…”