Table 2

Further study data from the clinical studies (identified in table 1) investigating the basal-plus principle

StudyStudy groupBaseline HbA1c
(%)
ΔHbA1c vs baseline
(%)
HbA1c <7% target
(%)
Baseline FBG
(mg/dL)
ΔFBG vs baseline
(mg/dL)
Baseline weight
(kg)
Δ weight vs baseline
(kg)
All hypo
(%/events PPY)
Severe hypo
(events PPY)
IGlar + IGlu
OPAL8 B+ (breakfast)7.35±0.71−0.3136.5108.1±14.4+12.6*89.7±16.6+1.0*34.2/2.720.01±0.15
B+ (main meal)7.29±0.69−0.3652.2106.3±14.4+7.2*89.4±17.6+0.9*37.1/3.690.04±0.30
Davidson et al 9 B+ 17.85±0.9−0.4430133.4±63.4107±26.3+3.80.28
B+ 27.79±0.8−0.3633127.7±43.5108±23.2+4.10.89
BB7.82±0.8−0.4346134.5±51.0104±24.9+3.90.64
POC21 B+ 7.8±0.6−0.37±0.0922.4111.9±22.691.5±16.6+0.7*–/13.4±21.70.0±0.0
BOT8.0±0.7−0.11±0.088.8110.9±22.592.9±17.2+0.4*–/11.1±15.50.2±1.1
Choe et al 13 B+ 8.5 (8.0–9.6)−0.7*13.8126.8±46.1−3.59.2/–
ELEONOR15 17 B+ (telecare)8.83±0.94−0.7±0.0645.2209.0†−111.7†*80.5±14.1+0.4±3.4–/1.89‡0.04
B+ (SMBG)8.89±0.95−0.7±0.0654.8212.6†−111.7†*82.5±15.2+0.4±5.1–/1.76‡0.02
OSIRIS20 BB8.5±1.1−0.72±1.2527.1104.2±10.382.7±15.6+2.03±0.27
B+ 8.4±1.1−0.47±1.0518.4103.9±11.381.6±15.8+1.29±0.23
B++IS8.3±1.1−0.40±1.1122.3106.1±9.383.6±17.0+1.92±0.30
Umpierrez et al 18 19 B+ 8.3±2.398±285/–
SSI8.0±2.195±293/–
BB8.7±2.596±2416/–
All To Target16 Basal +19.4±1.7−2.1±0.149198.2±70.3−79.3±73.997.2±20.95.0±6.562.5‡/–0.1±0.0
Basal +≤39.4±1.7−2.2±0.145207.2±75.7−86.5±90.195.2±19.26.8±7.660.1‡/–0.2±0.1
Premix9.3±1.6−1.8±0.139203.6±64.9−61.3±72.198.2±20.56.4±6.972.0‡/–0.2±0.1
LanScape23 B+ 8.6±0.9−1.0020.6109.9±28.891.5±15.7+2.06–/15.3
Premix8.6±0.9−1.2227.9108.1±28.890.8±15.4+2.50–/18.2
Jin et al 22 B+ 8.3±0.7−0.9±0.133.3105.1±20.3+3.1±3.664.9±9.4+1.22±0.3776.90/–
Premix8.5±0.7−1.0±0.129.3107.8±22.8+24.4±3.563.9±9.8+1.05±0.3671.95/–
GetGoal Duo-224 B+ 7.7±0.6−0.6±0.138.4123±36−0.2±0.188.4±15.9+1.0±0.346.5‡/–
Lixisenatide7.9±0.6−0.6±0.142.1119±33−0.2±0.190.1±17.4−0.6±0.335.9‡/–
BB7.8±0.6−0.8±0.149.2120±34−0.1±0.190.0±17.2+1.4±0.352.3‡/–
IGlar + ILis
Tinahones et al 26 B+8.6±0.7−1.0830.0111.7±32.43+13.5178.5±15.2+0.5062.5/26.440
Premix8.7±0.8−1.3034.5115.3±36.0+16.0478.7±15.6+1.1361.0/13.070.04±0.45
Gracia-Ramos et al 25 B+ 9.1±1.616/–
Premix9.7±1.916/–
Gross et al 14 B+ (MM=breakfast)8.7±0.8−1.1115.3±34.276.7±17.0+0.9–/12.0
B+ (MM=lunchtime)8.7±0.7−1.1113.5±37.880.2±14.6+0.7–/11.4
B+ (MM=evening)8.4±0.7−1.1106.3±25.277.5±15.2+0.4–/24.4
Premix (MM=breakfast)8.4±0.7−1.3113.5±28.878.2±17.6+1.6–/13.2
Premix (MM=lunch)8.8±0.8−1.4118.9±41.478.5±14.7+1.1–/12.1
Premix (MM=evening)8.7±0.8−1.3115.3±37.879.1±15.3+1.3–/13.6
IDet + IAsp
STEPWise28 B+ (SimpleSTEP)8.7±1.0−1.1±1.131146±52−11±6888.0±16.3+2.7±3.974.0/9.70.04
B+ (ExtraSTEP)8.9±1.2−1.3±1.227149±52−16±5888.8±15.8+2.0±3.877.4/9.120.01
FullSTEP27 B+ 7.9±0.6−0.9855.9126.1±34.2+2.2*88.9±18.7+0.4*
BB7.9±0.6−1.1263.3124.3±28.8−2.0*86.1±15.2+3.7*
  • Of the above studies, only the studies by Umpierrez et al and Gracia-Ramos et al were inpatient studies. A minus symbol in front of a number indicates a loss in value, whereas a plus sign in front of a number indicates a gain in value.

  • *Calculated from baseline and endpoint means.

  • †Estimates based on figure (no exact values given).

  • ‡All symptomatic hypoglycemia.

  • –, data not available; B+, basal-plus; basal +1, basal plus once daily insulin glargine injection; basal +≤3, basal plus up to three daily insulin glargine injections; BB, basal-bolus;BOT, basal-supported oral therapy; FBG, fasting blood glucose;HbA1c, glycosylated hemoglobin; hypo, hypoglycemia;IAsp, insulin aspart; IDet, insulin detemir; IGlar, insulin glargine; IGlu, insulin glulisine; ILis, insulin lispro; IS, insulin secretagogue; MM, main meal; PPY, per patient-year ; SMBG, self-monitored blood glucose; SSI, sliding scale insulin.